Methods And Systems For High-Throughput Blood Component Collection

ABSTRACT

Methods and devices for separating components from multi-component fluids are provided. A method for collecting a blood component includes drawing whole blood into a centrifuge, spinning the centrifuge to cause centrifugal force to act on the whole blood to separate the whole blood into a least a first blood component and a second blood component that is different from the first blood component, extracting the first blood component from the centrifuge, detecting when the second blood component is about to be extracted from the centrifuge, and after the second blood component is detected and while the centrifuge continues to spin, flowing the separated first blood component back towards the centrifuge to move at least the second blood component from the centrifuge.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefits of U.S. Provisional Application No.63/394,417 filed Aug. 2, 2022. The entire disclosure of the aboveapplication is incorporated herein by reference.

FIELD

The present disclosure is generally directed to separating componentsfrom multi-component fluids, in particular, toward apheresis methods andsystems.

BACKGROUND

There are two common methods for blood donation/collection. The first iswhole blood donation from a donor, followed by a centrifugal processthat separates blood components from the whole blood based on thedensity of the blood component. The desired component can be manually,semi-automatically, or automatically moved to a collection containerduring, or possibly, after the whole blood is under the effect of theforces produced by the centrifuge. The other method may be an apheresiscollection that requires a specialized machine.

The apheresis method extracts whole blood from a donor while the donoris connected to the specialized machine. The whole blood can again becentrifuged to collect only the blood component (e.g., plasma) that isdesired and can return all other blood components not desired back tothe donor during the same donation. The donor is connected to theapheresis machine during the separation and collection of the bloodcomponent. Unfortunately, the apheresis process can be lengthy anduncomfortable. Often, the donor must remain connected to the machine foran hour to obtain a blood component donation. Thus, making the donationprocedure more efficient is an ongoing desire for apheresis collectionsites.

SUMMARY

There is a need for a plasma or other blood component system that canreduce the donation time and increase the comfort of the donor.Embodiments presented herein can increase the efficiency of the donationprocess by using the separated blood component to push or drive thenon-desired blood components back to the donor without stopping andrestarting the centrifuge. Thus, the embodiments herein make thedonation process more efficient and faster for the donor.

Embodiments may also provide methods and apparatuses for positioningportions (e.g., loops) of disposables in medical devices. Embodimentsmay involve use of surfaces for automatically guiding loops. In at leastone example embodiment, the medical devices may be blood separationmachines, such as apheresis machines.

The previously mentioned and other needs are addressed by the variousaspects, embodiments, and/or configurations of the present disclosure.Also, while the disclosure is presented in terms of exemplaryembodiments, it should be appreciated that individual aspects of thedisclosure can be separately claimed.

In at least one example embodiment, the present disclosure provides anassembly for separating a component from a multi-component fluid. Theassembly may include a filler that includes a channel for holding aseparation bladder of a disposable, where the channel includes twoopposing walls. The assembly may also include a loop rotational positionguide that includes a plurality of bearings. The loop rotationalposition guide may hold a flexible loop of a disposable when theseparation bladder is loaded in the channel.

In at least one example embodiment, the loop rotational position guidemay include a stop plate. In at least one example embodiment, theflexible loop may contact the stop plate when held in the looprotational position guide. In at least one example embodiment, theassembly may form part of an apheresis machine. In at least one exampleembodiment, the assembly may be connected to a rotor that is configuredto rotate the loop rotational position guide around an axis of rotation.In at least one example embodiment, the plurality of bearings mayinclude a plurality of pairs of roller bearings.

In at least one example embodiment, the present disclosure provides acentrifuge assembly. The centrifuge assembly may include a centrifugehousing having an outer surface and an internal cavity, where thecentrifuge housing rotates about a rotation axis of the centrifugeassembly; a fluid separating body disposed at least partially within theinternal cavity of the centrifuge housing and configured to rotaterelative to the centrifuge housing about the rotation axis; and a fluidline loop arm attached to a portion of the centrifuge housing andrunning along a length of the outer surface of the centrifuge housing.The fluid line loop arm may include a bearing set disposed at a pointalong the length of the outer surface. The bearing set may be configuredto contact a tubing portion of an interconnected fluid line loop andmaintain the fluid line loop in an engaged position relative to thecentrifuge housing while allowing the fluid line loop to rotate in theengaged position.

In at least one example embodiment, the bearing set includes a pair ofroller bearings. In at least one example embodiment, the bearing setincludes a plurality of pairs of roller bearings. In at least oneexample embodiment, the centrifuge assembly may be part of an apheresismachine. In at least one example embodiment, the fluid line loop may beaffixed to a static nonrotating portion of the apheresis machine at afirst end of the fluid line loop via a first positively-locatedconnector, and the fluid line loop may be interconnected to the fluidseparating body within the internal cavity at a second end of the fluidline loop via a second positively-located connector. In at least oneexample embodiment, the second end of the fluid line loop may rotatewith the fluid separating body. In at least one example embodiment, thefluid line loop may be physically and fluidly attached to a disposablefluid separation bladder at the second positively-located connector. Inat least one example embodiment, the fluid line loop may include aplurality of lumens, and the fluid separation bladder may include afirst flexible sheet attached to a second flexible sheet forming a fluidpathway. A first portion of the fluid pathway may be narrow compared toa second portion of the fluid pathway.

In at least one example embodiment, the present disclosure provides amethod for automatically loading a fluid line loop into a centrifugeassembly. The method may include attaching the fluid line loop at afirst end to a fluid separating body of the centrifuge assembly androtating the fluid separating body in a first rotational directionrelative to a housing of the centrifuge assembly, where rotating thefluid separating body may cause the fluid line loop to rotate relativeto the housing and guide into a channel of a loop arm attached to aportion of the housing. The channel may include bearings disposed in abearing set attached to the loop arm. The bearings may hold the fluidline loop in a position relative to the housing as the centrifugeassembly rotates.

In at least one example embodiment, the bearings may contact a portionof the fluid line loop as the fluid line loop rotates inside the channelin the position relative to the housing. In at least one exampleembodiment, the centrifuge housing may rotate in the first rotationaldirection at a first angular velocity about a rotation axis and thefluid separating body may be caused to rotate at a different secondangular velocity about the rotation axis via a twisting force providedby the fluid line loop. In at least one example embodiment, the secondangular velocity may be substantially two times the first angularvelocity. In at least one example embodiment, the fluid line loop may bephysically and fluidly attached to a disposable fluid separation bladderdisposed at least partially within the fluid separating body. In atleast one example embodiment, the method may further include attaching asecond end of the fluid line loop to a rotationally fixed point of anapheresis machine and rotating, via a rotor and motor assembly of theapheresis machine, the centrifuge assembly about the rotation axisrelative to the rotationally fixed point of the apheresis machine.

In at least one example embodiment, the present disclosure provides amethod for collecting a blood component through apheresis. The methodmay include drawing whole blood into a centrifuge from a donor, spinningthe centrifuge to cause centrifugal force to act on the whole blood toseparate the whole blood into a least a first blood component and athird blood component, separating a first blood component from the wholeblood, extracting the first blood component into a container, detectingwhen a second blood component is being extracted, and after the secondblood component is detected and while the centrifuge continues to spin,flowing the separated first blood component back towards the centrifugeto move at least the third blood component from the centrifuge and backinto the donor.

In at least one example embodiment, the first blood component mayinclude of plasma, platelets, red blood cells, high hematocrit blood, orany combination thereof. In at least one example embodiment, the secondblood component may include plasma, platelets, red blood cells, highhematocrit blood, or any combination thereof. In at least one exampleembodiment, the third blood component may include plasma, platelets, redblood cells, high hematocrit blood, or any combination thereof. In atleast one example embodiment, the first blood component may include twoor more of plasma, platelets, red blood cells, high hematocrit blood, orany combination there. In at least one example embodiment, thecentrifuge may spin at a first speed when separating the first bloodcomponent from the whole blood. In at least one example embodiment, thecentrifuge may continue to spin at the first speed when flowing theseparated first blood component back towards the centrifuge. In at leastone example embodiment, the centrifuge may spin at a second speed whendrawing whole blood into the centrifuge from the donor. In at least oneexample embodiment, the second speed may be slower than the first speed.In at least one example embodiment, the first blood component may beseparated from the whole blood in a blood component collection set thatis inserted into the centrifuge. In at least one example embodiment, thecentrifuge may include a filler that spins a blood component separationbladder associated with the blood component collection set. In at leastone example embodiment, the blood component separation bladder may beinserted into a separation insert channel formed in the filler to holdthe blood component separation bladder.

In at least one example embodiment, the present disclosure provides anapheresis system. The apheresis system may include a first tube having alumen, fluidly associated with the needle, that moves whole blood from adonor through the lumen; a draw pump engaged with the first tube thatdraws the whole blood into a centrifuge from the donor; the centrifugethat spins to cause centrifugal force to act on the whole blood toseparate the whole blood into a least a first blood component and athird blood component; a blood component separation bladder, insertedinto the centrifuge and fluidly associated with the first tube, thatseparates the first blood component from the whole blood; a second tube,fluidly associated the blood separation bladder, that moves the firstblood component from the blood component separation bladder; acollection container, fluidly associated with the second tube, thatextracts the first blood component from the apheresis system; a sensorpositioned in physical proximity to the second tube to detect when asecond blood component is being extracted from the whole blood; andafter the second blood component is detected by the sensor and while thecentrifuge continues to spin, a return pump, engaged with the secondtube, that forces the separated first blood component back towards theblood component separation bladder through the second tube to move atleast the third blood component from the blood component separationbladder and back into the donor.

In at least one example embodiment, the first blood component mayinclude plasma and the second blood component may include platelets, redblood cells, high hematocrit blood, or a combination thereof. In atleast one example embodiment, the apheresis system may further includean anticoagulant pump configured to draw anticoagulant from ananticoagulant bag and to mix the anticoagulant with whole blood at amanifold or junction fluidly associated with the first tube. In at leastone example embodiment, the centrifuge may include a filler that spinsthe blood component separation bladder. In at least one exampleembodiment, the blood component separation bladder may be inserted intoa separation insert channel formed in the filler to hold the bloodcomponent separation bladder.

In at least one example embodiment, the present disclosure provides ablood component collection set that may be associated with an apheresissystem. The blood component collection set may include a needle insertedinto a blood vessel of a donor to draw whole blood from a donor; a firsttube having a lumen, fluidly associated with the needle, that moves thewhole blood through the lumen, where a draw pump engaged with the firsttube draws the whole blood from the donor; a blood component separationbladder, inserted into a centrifuge and fluidly associated with thefirst tube, that separates the first blood component and a thirdcomponent from the whole blood; a second tube, fluidly associated withthe blood separation bladder, that moves the first blood component fromthe blood component separation bladder; and a collection containerfluidly associated with the second tube that extracts the first bloodcomponent from the apheresis system, where a sensor is positioned inphysical proximity to the second tube to detect when a second bloodcomponent is being extracted from the whole blood; and where, after thesecond blood component is detected by the sensor and while thecentrifuge continues to spin, a return pump engaged with the second tubeforces the separated first blood component back towards the bloodcomponent separation bladder through the second tube to move at leastthe third blood component from the blood component separation bladderand back into the donor.

In at least one example embodiment, the first blood component mayinclude plasma, and the second blood component may include platelets. Inat least one example embodiment, the draw pump may be disengaged whenthe return pump forces the separated first blood component back towardsthe blood component separation bladder through the second tube to moveat least the third blood component from the blood component separationbladder and back into the donor. In at least one example embodiment, theblood component separation bladder may be inserted and held in a filler,in the centrifuge, that spins the blood component separation bladder. Inat least one example embodiment, the blood component separation bladdermay be inserted into a separation insert channel formed in the filler tohold the blood component separation bladder.

In at least one example embodiment, the present disclosure provides afiller for holding a separation bladder in which a component isseparated from a composite fluid. The filler may include a channel forholding a separation bladder during separation of the component from thecomposite fluid, the channel including a first wall and a second wallopposite the first wall; and where a first end of the channel isadjacent a central portion of the filler and the channel spirals towardan outside perimeter of the filler.

In at least one example embodiment, atop portion of the channel may benarrower than a middle portion of the channel. In at least one exampleembodiment, at least a portion of the second wall may have a concavesurface. In at least one example embodiment, the second end of thechannel may be located so that it experiences a higher gravitationalforce during separation than the first end. In at least one exampleembodiment, the top portion of the channel may provide reinforcement tothe separation bladder during separation.

In at least one example embodiment, the present disclosure provides afluid separation filler. The fluid separation filler may include a bodyhaving a rotation axis substantially disposed at a mass center of thebody and a fluid separation insert channel disposed in the body andfollowing a substantially spiral path running from a first pointadjacent to the rotation axis spirally outward to a second pointdisposed adjacent to a periphery of the body, where the fluid separationinsert channel may jog outwardly toward the periphery of the body nearan end of the substantially spiral path defining a third point of thefluid separation insert channel disposed furthest from the rotationaxis.

In at least one example embodiment, the fluid separation filler mayfurther include a fluid collection chamber disposed within the body andfollowing a portion of the substantially spiral path, where the fluidseparation insert channel connects to the fluid collection chamberdefining access area between an interior of the fluid collection chamberand an exterior of the body. In at least one example embodiment, thefluid collection chamber may be configured to receive a disposable fluidseparation bladder. In at least one example embodiment, a dimension fromthe rotation axis to the third point of the substantially spiral pathmay be greater than a dimension from the rotation axis to the secondpoint of the substantially spiral path. In at least one exampleembodiment, a width of the fluid collection chamber at a point along thesubstantially spiral path may be greater than a width of the fluidseparation insert channel at the point along the substantially spiralpath. In at least one example embodiment, the fluid collection chambermay further include a first wall following an innermost portion of thesubstantially spiral path and a second wall substantially parallel tothe first wall and following an outermost portion of the substantiallyspiral path. In at least one example embodiment, the fluid collectionchamber may further include one or more tapered walls disposed betweenthe first wall and the second wall, and where the one or more taperedwalls are configured to guide the disposable fluid separation bladderinto a seated position within the fluid collection chamber. In at leastone example embodiment, a fluid inlet for the disposable fluidseparation bladder when installed in the fluid collection chamber may bedisposed adjacent to the rotation axis and a first fluid path in thedisposable fluid separation bladder may follow the substantially spiralpath outwardly toward an end of the disposable fluid separation bladderdisposed adjacent to the third point of the fluid separation insertchannel disposed furthest from the rotation axis, and fluidlyinterconnects with a second fluid path separated from the first fluidpath in the disposable fluid separation bladder running in a directionfrom the third point following the substantially spiral path inwardlytoward a fluid outlet for the disposable fluid separation bladderdisposed adjacent to the rotation axis. In at least one exampleembodiment, the fluid inlet and the fluid outlet may be part of aconnector attached to the disposable fluid separation bladder, and wherethe body of the fluid separation filler may include a connection pointthat engages with the connector. In at least one example embodiment, theconnector may include at least one key feature, where the connectionpoint includes at least one mating key feature, and where the keyfeatures positively locate the connector relative to the connectionpoint.

In at least one example embodiment, the present disclosure provides acentrifuge assembly. The centrifuge assembly may include a centrifugehousing having an internal cavity, where the centrifuge housing rotatesabout a rotation axis of the centrifuge assembly, and a fluid separatingbody disposed at least partially within the internal cavity of thecentrifuge housing and configured to rotate relative to the centrifugehousing about the rotation axis, where the fluid separating bodyincludes a fluid separation insert channel disposed in the fluidseparating body following a substantially spiral path running from afirst point adjacent to the rotation axis spirally outward to a secondpoint disposed adjacent to a periphery of the fluid separating body, andwhere the fluid separation insert channel jogs outwardly toward theperiphery of the body near an end of the substantially spiral pathdefining a third point of the fluid separation insert channel disposedfurthest from the rotation axis.

In at least one example embodiment, the fluid separating body mayfurther include a fluid collection chamber disposed within the body andfollowing a portion of the substantially spiral path, where the fluidseparation insert channel connects to the fluid collection chamberdefining an access area between an interior of the fluid collectionchamber and an exterior of the fluid separating body. In at least oneexample embodiment, the centrifuge assembly may further include adisposable fluid separation bladder disposed within the fluid collectionchamber following the substantially spiral path, where the disposablefluid separation bladder includes a fluid inlet disposed adjacent to therotation axis and a first fluid path in the disposable fluid separationbladder follows the substantially spiral path outwardly toward an end ofthe disposable fluid separation bladder disposed adjacent to the thirdpoint of the fluid separation insert channel disposed furthest from therotation axis and fluidly interconnects with a second fluid pathseparated from the first fluid path in the disposable fluid separationbladder running in a direction from the third point following thesubstantially spiral path inwardly toward a fluid outlet for thedisposable fluid separation bladder disposed adjacent to the rotationaxis. In at least one example embodiment, the centrifuge assembly may bepart of an apheresis machine. In at least one example embodiment, thecentrifuge housing may be split into an upper housing and a lowerhousing, where the upper housing may include the internal cavity, wherethe upper housing may be rotatable between an open state and a closedstate about a pivot axis that is offset and substantially perpendicularto the rotation axis, and where the fluid separation insert channel ofthe fluid separating body may be accessible in the open state andinaccessible in the closed state.

In at least one example embodiment, the present disclosure provides ablood component collection loop. The blood component collection loop mayinclude a flexible loop; a system static loop connector disposed at afirst end of the flexible loop, where the system static loop connectoris connected to the fixed loop connection of a centrifuge to fix thefirst end of the flexible loop to rotate in unison with the centrifuge;a filler loop connector disposed at a second end, opposite the firstend, of the flexible loop, where the filler loop connector may beconnected to a loop connection area of a filler, and where torsionalforces based on twist in the flexible loop are imparted to the fillerthrough the filler loop connector; and where flexible loop may berotationally moved to be captured by a loop rotational position guidepositioned on the centrifuge.

In at least one example embodiment, the blood component collection loopmay be part of a blood component collection set, and where the bloodcomponent collection set may be associated with an apheresis system. Inat least one example embodiment, the loop rotational position guide maybe attached to a rotor that rotates the loop rotational position guideand the flexible loop around an axis of rotation. In at least oneexample embodiment, the blood component collection loop may be at leastpartially positioned by a loop position stop plate. In at least oneexample embodiment, the flexible loop may be curved around thecentrifuge. In at least one example embodiment, the flexible loops maybe also held in position by a loop containment bracket. In at least oneexample embodiment, at least a portion of the loop rotational positionguide may include a loop twist support bearing. In at least one exampleembodiment, the loop twist support bearing may include a pair of rollerbearings. In at least one example embodiment, the loop twist supportbearing may allow the flexible loop to twist. In at least one exampleembodiment, the twist may cause the filler to rotate at a greaterangular velocity than the centrifuge. In at least one exampleembodiment, the flexible loop may include two or more lumens to movewhole blood and/or blood components within the flexible loop.

In at least one example embodiment, the present disclosure provides anassembly for loading a flexible loop. The assembly may include a looprotation position guide that includes a channel for holding a flexibleloop of a blood component collection set; a loop twist support bearing,disposed in the channel and on a portion of the loop rotation positionguide, to support the flexible loop; and a loop capture arm, where theloop capture arm may be positioned adjacent the channel and connected tothe loop rotation position guide, to guide the flexible loop into thechannel and in contact with the loop twist support bearing.

In at least one example embodiment, the assembly may be part of anapheresis machine, and where the loop rotation position guide may beattached to centrifuge that rotates the loop rotation position guide andthe flexible loop around an axis of rotation. In at least one exampleembodiment, the loop rotation position guide may further include a loopposition stop plate to further position the flexible loop. In at leastone example embodiment, the assembly may further include a loopcontainment bracket, positioned in a plane with the loop rotationposition guide and disposed on the centrifuge, to further capture theflexible loop.

In at least one example embodiment, the present disclosure provides amethod for automatically loading a flexible loop into an assembly. Themethod may include connecting a system static loop connector, disposedat a first end of the flexible loop, to a fixed loop connection of acentrifuge to fix the first end of the flexible loop to rotate in unisonwith the centrifuge; connecting a filler loop connector, disposed at asecond end, opposite the first end, of the flexible loop, to a loopconnection area of a filler, and where torsional forces based on twistin the flexible loop are imparted to the filler through the filler loopconnector; and rotationally moving the flexible loop into a looprotational position guide positioned on the centrifuge.

In at least one example embodiment, the flexible loop may engage a looptwist support bearing, disposed in a channel formed by the loop rotationposition guide, where the loop twist support bearing supports theflexible loop. In at least one example embodiment, a loop capture armmay contact the flexible loop when rotating to guide the flexible loopinto the channel and in contact with the loop twist support bearing. Inat least one example embodiment, the loop rotation position guide mayfurther include a loop position stop plate to prevent over-rotation ofthe flexible loop past the channel. In at least one example embodiment,a loop containment bracket, positioned in a plane with the loop rotationposition guide and disposed on the centrifuge may further captures andholds the flexible loop.

In at least one example embodiment, the present disclosure provides asoft cassette. The soft cassette may include a first cassette port; asecond cassette port; a direct flow lumen fluidly connected to the firstcassette port and the second cassette port; a drip chamberinter-disposed in the direct flow lumen such that the fluid passingthrough the direct flow lumen passes through the drip chamber; and afluid flow bypass path both fluidly connected to the direct flow lumenadjacent the first cassette port and between the first cassette port andthe drip chamber and fluidly connected to the direct flow lumen adjacentthe second cassette port and between the second cassette port and thedrip chamber, such that fluid flowing through the fluid flow bypass pathbypasses the drip chamber.

In at least one example embodiment, the fluid flow bypass path mayinclude a first bypass branch fluidly connected to the direct flow lumenadjacent the first cassette port and a second bypass branch fluidlyconnected to the direct flow lumen adjacent the second cassette port. Inat least one example embodiment, the fluid flow bypass path may furtherinclude a fluid pressure annulus disposed between and fluidly connectedto the first bypass branch and the second bypass branch. In at least oneexample embodiment, the direct flow lumen may include a first compliantregion, disposed between a first connection with the first bypass branchand the drip chamber, that allows a first fluid control valve to occludethe direct flow lumen. In at least one example embodiment, the directflow lumen may include a second compliant region, disposed between asecond connection with the second bypass branch and the drip chamber,that allows a second fluid control valve to occlude the direct flowlumen. In at least one example embodiment, the direct flow lumen mayinclude a third compliant region, disposed in the first bypass branch,that allows a draw fluid control valve to occlude the first bypassbranch. In at least one example embodiment, the first cassette port maybe fluidly connected to a cassette inlet tubing that moves fluid from adonor into the soft cassette or fluid from the soft cassette to thedonor, and where the second cassette port may be fluidly connected to aloop inlet tubing that moves fluid from a soft cassette into thecentrifuge or fluid from the centrifuge to the soft cassette. In atleast one example embodiment, when drawing fluid from the donor, thefluid may pass through the fluid flow bypass path. In at least oneexample embodiment, when sending fluid to the donor, the fluid may passthrough the direct flow lumen. In at least one example embodiment, whendrawing fluid from the donor in a subsequent draw, a portion of thefluid previously sent to the donor through the direct flow lumen may bemaintained in the drip chamber when the fluid passes through the fluidflow bypass path. In at least one example embodiment, the soft cassettemay be part of a blood component collection set. In at least one exampleembodiment, the blood component collection set may be part of anapheresis system.

In at least one example embodiment, the present disclosure provides ablood component collection set. The blood component collection set mayinclude a centrifuge to separate blood components from whole blood; acassette inlet tubing fluidly connected to a donor; a loop inlet tubingfluidly connected to the centrifuge; a soft cassette that includes afirst cassette port fluidly connected to the cassette inlet tubing, asecond cassette port fluidly connected to the loop inlet tubing, adirect flow lumen fluidly connected to the first cassette port and thesecond cassette port, a drip chamber inter-disposed in the direct flowlumen such that the fluid passing through the direct flow lumen passesthrough the drip chamber, and a fluid flow bypass path both fluidlyconnected to the direct flow lumen adjacent the first cassette port andbetween the first cassette port and the drip chamber and fluidlyconnected to the direct flow lumen adjacent the second cassette port andbetween the second cassette port and the drip chamber, such that fluidflowing through the fluid flow bypass path bypasses the drip chamber.

In at least one example embodiment, the fluid flow bypass path mayinclude a first bypass branch fluidly connected to the direct flow lumenadjacent the first cassette port; a second bypass branch fluidlyconnected to the direct flow lumen adjacent the second cassette port;and a fluid pressure annulus disposed between and fluidly connected tothe first bypass branch and the second bypass branch. In at least oneexample embodiment, the direct flow lumen may include a first compliantregion, disposed between a first connection with the first bypass branchand the drip chamber, that allows a first fluid control valve to occludethe direct flow lumen, where the direct flow lumen includes a secondcompliant region, disposed between a second connection with the secondbypass branch and the drip chamber, that allows a second fluid controlvalve to occlude the direct flow lumen, and where the direct flow lumenincludes a third compliant region, disposed in the first bypass branch,that allows a draw fluid control valve to occlude the first bypassbranch. In at least one example embodiment, when drawing fluid from thedonor, the first fluid control valve and the second fluid flow controlvalve are closed and occlude the direct flow lumen and the draw fluidcontrol valve is open and allows whole blood to pass through the fluidflow bypass path. In at least one example embodiment, when sending fluidto the donor, the first fluid control valve and the second fluid flowcontrol valve are open and allow fluid to pass through the direct flowlumen, and the draw fluid control valve is closed and occludes the fluidflow bypass path. In at least one example embodiment, when drawing fluidfrom the donor in a subsequent draw, a portion of the fluid previouslysent to the donor through the direct flow lumen may be maintained in thedrip chamber when the fluid passes through the fluid flow bypass path.

In at least one example embodiment, the present disclosure provides amethod for moving fluids through a soft cassette. The method may includeproviding a soft cassette, where the soft cassette includes a firstcassette port fluidly connected to a cassette inlet tubing, a secondcassette port fluidly connected to a loop inlet tubing, a direct flowlumen fluidly connected to the first cassette port and the secondcassette port, a drip chamber inter-disposed in the direct flow lumensuch that the fluid passing through the direct flow lumen passes throughthe drip chamber, and a fluid flow bypass path both fluidly connected tothe direct flow lumen adjacent the first cassette port and between thefirst cassette port and the drip chamber and fluidly connected to thedirect flow lumen adjacent the second cassette port and between thesecond cassette port and the drip chamber, such that fluid flowingthrough the fluid flow bypass path bypasses the drip chamber; whendrawing whole blood from a donor; receiving whole blood from thecassette inlet tubing at a first cassette port fluidly connected to thecassette inlet tubing; moving the whole blood through the fluid flowbypass path to the second cassette port; preventing whole blood frommoving through the direct lumen; and when returning red blood cells tothe donor, receiving red blood cells from the loop inlet tubing at asecond cassette port fluidly connected to the loop inlet tubing. movingthe red blood cells through the direct flow lumen and the drip chamberto the first cassette port. and preventing red blood cells from movingthrough the fluid flow bypass path.

In at least one example embodiment, when drawing fluid from the donor ina subsequent draw, a portion of the fluid previously sent to the donorthrough the direct flow lumen, when returning red blood cells to thedonor, may be maintained in the drip chamber when the whole blood againpasses through the fluid flow bypass path.

Any one or more of the aspects/embodiments as substantially disclosedherein. optionally in combination with any one or more otheraspects/embodiments as substantially disclosed herein.

One or more means adapted to perform any one or more of the aboveaspects/embodiments as substantially disclosed herein.

The present disclosure can provide a number of advantages depending onthe particular aspect, embodiment, and/or configuration. By maintainingthe speed of rotation of the centrifuge while moving the unneeded bloodcomponents back to the donor, the apheresis procedure can be reduced intime, possibly by 30% or more. This increase in efficiency allows forfaster and more comfortable donations. With faster donation times, adonation center can obtain more donations in a typical day, whichincreases productivity and revenue. Further, donors are more likely toreturn to donate again if the donation is faster. Having fasterdonations may also allow donation centers to attract donors using otherdonation centers with slower donation speeds.

The phrases “at least one”, “one or more”, and “and/or” are open-endedexpressions that are both conjunctive and disjunctive in operation. Forexample, each of the expressions “at least one of A, B and C”, “at leastone of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B,or C” and “A, B, and/or C” means A alone, B alone, C alone, A and Btogether, A and C together, B and C together, or A, B and C together.

The term “a” or “an” entity refers to one or more of that entity. Assuch, the terms “a” (or “an”), “one or more” and “at least one” can beused interchangeably herein. It is also to be noted that the terms“comprising”, “including”, and “having” can be used interchangeably.

The term “donor,” as used herein, can mean any person providing a fluid(e.g., whole blood) to the apheresis system. A donor can also be apatient that also provides a fluid to the apheresis system temporarilywhile the fluid is processed, treated, and/or manipulated before beingprovided back to the patient.

The term “automatic” and variations thereof, as used herein, refers toany process or operation done without material human input when theprocess or operation is performed. However, a process or operation canbe automatic, even though performance of the process or operation usesmaterial or immaterial human input, if the input is received beforeperformance of the process or operation. Human input is deemed to bematerial if such input influences how the process or operation will beperformed. Human input that consents to the performance of the processor operation is not deemed to be “material”.

The term “computer-readable medium” as used herein refers to anytangible storage and/or transmission medium that participate inproviding instructions to a processor for execution. Such a medium maytake many forms, including but not limited to, non-volatile media,volatile media, and transmission media. Non-volatile media includes, forexample, NVRAM, or magnetic or optical disks. Volatile media includesdynamic memory, such as main memory. Common forms of computer-readablemedia include, for example, a floppy disk, a flexible disk, hard disk,magnetic tape, or any other magnetic medium, magneto-optical medium, aCD-ROM, any other optical medium, punch cards, paper tape, any otherphysical medium with patterns of holes, a RAM, a PROM, and EPROM, aFLASH-EPROM, a solid state medium like a memory card, any other memorychip or cartridge, a carrier wave as described hereinafter, or any othermedium from which a computer can read. A digital file attachment toe-mail or other self-contained information archive or set of archives isconsidered a distribution medium equivalent to a tangible storagemedium. When the computer-readable media is configured as a database, itis to be understood that the database may be any type of database, suchas relational, hierarchical, object-oriented, and/or the like.Accordingly, the disclosure is considered to include a tangible storagemedium or distribution medium and prior art-recognized equivalents andsuccessor media, in which the software implementations of the presentdisclosure are stored.

The term “module” as used herein refers to any known or later developedhardware, software, firmware, artificial intelligence, fuzzy logic, orcombination of hardware and software that is capable of performing thefunctionality associated with that element.

The terms “determine”, “calculate” and “compute,” and variationsthereof, as used herein, are used interchangeably, and include any typeof methodology, process, mathematical operation or technique.

It shall be understood that the term “means” as used herein shall begiven its broadest possible interpretation in accordance with 35 U.S.C.,Section 112, Paragraph 6. Accordingly, a claim incorporating the term“means” shall cover all structures, materials, or acts set forth herein,and all of the equivalents thereof. Further, the structures, materialsor acts and the equivalents thereof shall include all those described inthe summary of the invention, brief description of the drawings,detailed description, abstract, and claims themselves.

The preceding is a simplified summary of the disclosure to provide anunderstanding of some aspects of the disclosure. This summary is neitheran extensive nor exhaustive overview of the disclosure and its variousaspects, embodiments, and/or configurations. It is intended neither toidentify key or critical elements of the disclosure nor to delineate thescope of the disclosure but to present selected concepts of thedisclosure in a simplified form as an introduction to the more detaileddescription presented below. As will be appreciated, other aspects,embodiments, and/or configurations of the disclosure are possibleutilizing, alone or in combination, one or more of the features setforth above or described in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a perspective view illustrating an operating environment for anexample apheresis system in accordance with at least one exampleembodiment of the present disclosure;

FIG. 2A is a perspective view of the example apheresis system introducedin FIG. 1 ;

FIG. 2B is a perspective view of an example pump, for example, for usewith the example apheresis system introduced in FIG. 1 , in accordancewith at least one example embodiment of the present disclosure;

FIG. 2C is another perspective view of the example pump introduced inFIG. 2B;

FIG. 2D is a perspective view of an example fluid valve control system,for example, for use with the example apheresis system introduced inFIG. 1 , in accordance with at least one example embodiment of thepresent disclosure;

FIG. 3A is a perspective view of an example disposable soft cassetteassembly, for example, for use with the example apheresis systemintroduced in FIG. 1 , in accordance with at least one exampleembodiment of the present disclosure;

FIG. 3B is another perspective view of the example disposable softcassette introduced in FIG. 3A;

FIG. 3C is an elevation section view taken through line 3C of FIG. 3B;

FIG. 3D is an elevation section view taken through line 3D of FIG. 3B;

FIG. 4A is a perspective view of an example centrifuge assembly, forexample, for use with the example apheresis system introduced in FIG. 1, in accordance with at least one example embodiment of the presentdisclosure;

FIG. 4B is a front perspective view of the example centrifuge assemblyillustrated in FIG. 4A;

FIG. 4C is a rear perspective view of the example centrifuge assemblyillustrated in FIG. 4A;

FIG. 4D is a schematic section view of the example centrifuge assemblyintroduced in FIG. 4A in a closed state in accordance with at least oneexample embodiment of the present disclosure;

FIG. 4E is a schematic section view of the example centrifuge assemblyintroduced in FIG. 4A in a partially open state in accordance with atleast one example embodiment of the present disclosure;

FIG. 4F is a schematic section view of the example centrifuge assemblyintroduced in FIG. 4A in an open state in accordance with at least oneexample embodiment of the present disclosure;

FIG. 4G is a perspective view of an example filler, for example, for usewith the example centrifuge introduced in FIG. 4A in accordance with atleast one example embodiment of the present disclosure;

FIG. 4H is a plan view of the example filler introduced in FIG. 4G;

FIG. 4I is a schematic plan view of an example substantiallyspiral-shaped receiving channel, for example, for use with the examplefiller introduced in FIG. 4G, in accordance with at least one exampleembodiment of the present disclosure;

FIG. 4J is an elevation section view taken through line 4J of FIG. 4H;

FIG. 4K is a detail section view of a portion of a channel in theexample filler introduced in FIG. 4G;

FIG. 4L illustrates different states of fluid separation bladdersdisposed inside the channel in the example filler introduced in FIG. 4G;

FIG. 5A shows a schematic view of an example fluid component collectionset for example, for use with the example apheresis system introduced inFIG. 1 , in accordance with embodiments of the present disclosure;

FIG. 5B is an elevation view of the example fluid component collectionloop introduced in FIG. 5A;

FIG. 5C is a cross-section of an example bladder, for example, of theexample fluid component collection loop introduced in FIG. 5A, inaccordance with at least one embodiment of the present disclosure;

FIG. 5D is a cross-section of another example bladder, for example, ofthe example fluid component collection loop introduced in FIG. 5A, inaccordance with at least one embodiment of the present disclosure;

FIG. 5E is a perspective view of the example fluid component collectionloop introduced in FIG. 5A in a flexed state in accordance with at leastone example embodiment of the present disclosure;

FIG. 5F is a perspective view of the example fluid component collectionloop introduced in FIG. 5A in a loading state in accordance with atleast one example embodiment of the present disclosure;

FIG. 5G is a perspective view of the example fluid component collectionloop introduced in FIG. 5A loading into, for example, the example fillerintroduced in FIG. 4G, in accordance with at least one exampleembodiment of the present disclosure;

FIG. 5H is a perspective view of the example fluid component collectionloop introduced in FIG. 5A loaded into, for example, the example fillerintroduced in FIG. 4G, in accordance with at least one exampleembodiment of the present disclosure;

FIG. 6A is a schematic section view of the example centrifuge assemblyintroduced in FIG. 4A in a first loop-loading state in accordance withat least one example embodiment of the present disclosure;

FIG. 6B is a schematic section view of the example centrifuge assemblyintroduced in FIG. 4A in a second loop-loading state in accordance withat least one example embodiment of the present disclosure;

FIG. 6C is a schematic section view of the example centrifuge assemblyintroduced in FIG. 4A in a third loop-loading state in accordance withat least one example embodiment of the present disclosure;

FIG. 7A is a schematic plan view of the centrifuge assembly introducedin FIG. 4A in a loop-loaded state in accordance with at least oneexample embodiments of the present disclosure;

FIG. 7B is a schematic plan view of the example centrifuge assemblyintroduced in FIG. 4A in an operational state in accordance with atleast one example embodiment of the present disclosure;

FIG. 8 is a functional diagram for the example apheresis systemintroduced in FIG. 1 in accordance with at least one example embodimentof the present disclosure;

FIG. 9 is a block diagram of an example electrical system for theexample apheresis system introduced in FIG. 1 in accordance with atleast one example embodiments of the present disclosure;

FIG. 10 is a further block diagram of the example electrical systemintroduced in FIG. 9 ;

FIG. 11 is a further block diagram of the example electrical systemintroduced in FIG. 9 ;

FIG. 12 is a process diagram of an example method for conductingapheresis, for example, using the apheresis system introduced in FIG. 1, in accordance with at least one example embodiment of the presentdisclosure;

FIG. 13 is a process diagram of another example method for conductingapheresis, for example, using the apheresis system introduced in FIG. 1, in accordance with at least one example embodiment of the presentdisclosure;

FIG. 14 is a process diagram of another example method for conductingapheresis, for example, using the apheresis system introduced in FIG. 1, in accordance with at least one example embodiment of the presentdisclosure;

FIG. 15 is a process diagram of another example method for conductingapheresis, for example, using the apheresis system introduced in FIG. 1, in accordance with at least one example embodiment of the presentdisclosure;

FIG. 16 is a process diagram of an example method for inserting adisposable into a filler, like the filler introduced in introduced inFIG. 4G, in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17A is an example functional diagram of an apheresis system, likethe apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17B is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17C is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17D is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17E is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17F is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17G is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17H is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17I is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17J is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17K is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17L is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17M is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17N is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17O is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17P is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17Q is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17R is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure;

FIG. 17S is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure; and

FIG. 17T is another example functional diagram of an apheresis system,like the apheresis system introduced in FIG. 1 , during an apheresisprocedure in accordance with at least one example embodiment of thepresent disclosure.

In the appended drawing, similar components and/or features may have thesame reference label. Further, various components of the same type maybe distinguished by following the reference label by a letter thatdistinguishes among the similar components. If only the first referencelabel is used in the specification, the description is applicable to anyone of the similar components having the same first reference labelirrespective of the second reference label.

DETAILED DESCRIPTION

Embodiments of the present disclosure will be described in connectionwith apheresis methods and systems. Embodiments below may be describedwith respect to separating blood components from whole blood. However,this example procedure is provided simply for illustrative purposes. Itis noted that the embodiments are not limited to the description below.The embodiments are intended for use in products, processes, devices,and systems for separating any composite liquid. Accordingly, thepresent disclosure is not limited to separation of blood components fromwhole blood.

FIG. 1 is a perspective view of an example operating environment 100 ofan example apheresis system 200 in accordance with at least one exampleembodiment of the present disclosure. The operating environment 100 mayinclude an apheresis system 200, a donor 102, and one or moreconnections (e.g., donor feed tubing 104, cassette inlet tubing 108A,and/or anticoagulant tubing 110) running from the donor 102 to theapheresis system 200, and/or vice versa. For example, the donor feedtubing 104 may be fluidly connected with at least one blood vessel, forexample, a vein, of a donor 102 via venipuncture. For example, a cannulaconnected to an end of the donor feed tubing 104 may be inserted throughthe skin of the donor 102 and into the target site (e.g., vein). Thisconnection may provide an intravenous path for blood to flow from thedonor 102 to the apheresis system 200 and/or for blood components toflow back to the donor 102. In at least one example embodiment, thefluid paths and connections may form an extracorporeal tubing circuit ofthe apheresis system 200.

Blood supplied from the donor 102 may flow along the donor feed tubing104 through a tubing connector 106 and along a cassette inlet tubing108A into a soft cassette assembly 300. The soft cassette assembly 300may include one or more fluid control paths and valves for selectivelycontrolling the flow of blood to and/or from the donor 102. Theapheresis system 200 may include an anticoagulant supply contained in ananticoagulant (AC) bag 114. The anticoagulant may be pumped at leastthrough anticoagulant tubing 110 and the tubing connector 106 preventingthe coagulation of blood in the apheresis system 200.

Anticoagulants may include one or more of, but are not limited to,citrate and/or unfractionated heparin. The AC bag and other bags orbottles described herein may be made from, for example, one or more of,but not limited to, polyvinyl chloride (PVC), plasticized-PVC,polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone,thermoplastics, thermoplastic elastomer, polymers, copolymers, and/orcombinations thereof. The volume of AC in the AC bag 114 may vary basedon the various factors, including the mass of the donor 102, thevolumetric flow of blood from the donor. In one example, the volume inthe AC bag 114 may be 250 to 500 mL, although the volume in the AC bag114 may be more or less than this volume.

In at least one example embodiment, the apheresis system 200 may includea plasma collection bottle 122, or container, a saline fluid containedin a saline bag 118, and one or more lines or tubes 116, 120 (e.g.,fluid conveying tubing) connecting the saline bag 118 and the plasmacollection bottle 122 with the extracorporeal tubing circuit of theapheresis system 200. The amount of saline provided in the saline bag118 may be, for example, about 500 to 800 mL, although the volume in thesaline bag 118 may be more or less than this volume. An example donationof a blood component (e.g., plasma) may be 880 milliliters (mL). Thus,the plasma collection bottle 122 may hold at least this amount ofplasma. In at least one example embodiment, the plasma collection bottle122 may include a connection point disposed at, adjacent to, or inphysical proximity to, a substantially bottommost portion of the plasmacollection bottle 122 (e.g., when the plasma collection bottle 122 isinstalled in the plasma collection cradle 232C, as illustrated in FIG.2A). The connection point may include one or more connectors that areconfigured to interconnect with the plasma tubing 120 to receive and/orconvey plasma. The disposition of the connection point at the bottom ofthe plasma collection bottle 122 can allow plasma contained in theplasma collection bottle 122 to move out of the plasma tubing 120 backthrough the lines, as described herein, without trapping air bubbles. Inat least one example embodiment, the plasma collection bottle 122 may beconfigured as a flexible bag, rigid container, and/or other container,and thus, the plasma collection bottle 122 is not limited to bottles orbottle-like containers.

FIG. 2A shows a perspective view of the apheresis system 200 describedin FIG. 1 . The apheresis system 200 may provide for a continuous wholeblood separation process. In at least one example embodiment, wholeblood may be withdrawn from a donor 102 and substantially continuouslyprovided to a blood component separation device of the apheresis system200 where the blood may be separated into various components and atleast one of these blood components may be collected from the apheresissystem 200. In at least one example embodiment, one or more of theseparated blood components may be either collected, for subsequent use,or returned to the donor 102. The blood may be withdrawn from the donor102 and directed into a centrifuge of the apheresis system 200 throughan opening 220 in an access panel 224 of the apheresis system 200. In atleast one example embodiment, the tubing 104, 108A, 108B, 112, 116, 120,used in the extracorporeal tubing circuit may together define a closed,sterile, and disposable system, or blood component collection set, whichmay be further described hereinafter.

Examples of apheresis, plasmapheresis, and other separation systems thatmay be used with embodiments of the present disclosure (e.g., asapheresis system 200) include, but are not limited to, the SPECTRAOPTIA® apheresis system, COBE® spectra apheresis system, and the TRIMAACCEL® automated blood collection system, all manufactured by TerumoBCT, of Lakewood, Colorado.

Operation of the various pumps, valves, and blood component separationdevice, or centrifuge, may be controlled by one or more processorsincluded in the apheresis system 200. The one or more processors mayinclude, for example, a plurality of embedded computer processors thatare part of a computer system. The computer system may also includecomponents that allow a user to interface with the computer system,including for example, memory and storage devices (RAM, ROM (e.g.,CD-ROM, DVD), magnetic drives, optical drives, and/or flash memory);communication/networking devices (e.g., wired such as modems/networkcards, or wireless such as Wi-Fi); input devices such as keyboard(s),touch screen(s), camera(s), and/or microphone(s); and output device(s),such as display(s) and/or audio system(s). To assist the operator of theapheresis system 200 with various aspects of its operation, theembodiment of the blood component separation device, or centrifuge, mayinclude a graphical user interface with a display that includes aninteractive touch screen.

The apheresis system 200 may include a housing 204 and/or structuralframe, a cover 210, an access panel 224 disposed at a front 202 and/orrear 206 of the apheresis system 200, and one or more supports 232A-Cincluding hooks, rests, cradles, arms, protrusions, plates, and/or othersupport features for holding, cradling, and/or otherwise supporting abag or container 114, 118, 122. In at least one example embodiment, thefeatures of the apheresis system 200 may be described with reference toa coordinate system 103 and/or one or more axes thereof. The housing 204may include a machine frame (e.g., made of welded, bolted, and/orconnected structural elements, extruded material, and/or beams) to whichone or more panels, covers 210, doors, subassemblies, and/or componentsare attached. In at least one example embodiment, at least one panel ofthe apheresis system 200 may include a mounting surface for the softcassette assembly 300, one or more pumps 208, 212, 216, and/or a fluidvalve control system 228 (e.g., plasma and saline valve control).

The access panel 224 may include one or more handles, locks, and apivoting or hinged axis 226 (e.g., a door hinge, piano hinge, continuoushinge, and/or cleanroom hinge). In any event, the access panel 224 maybe selectively opened to provide access to an interior of the apheresissystem 200, and more specifically, to a blood separation assembly, orcentrifuge. In at least one example embodiment, the access panel 224 mayprovide access to load and/or unload the centrifuge with one or morecomponents in the blood component collection set.

The inside of the apheresis system 200 may be separated into at least acentrifuge portion and a controls portion. For instance, the centrifugeportion may include a cavity configured to receive the centrifuge,rotation motor, and associated hardware. This area may be physicallyseparated from the controls portion via one or more walls of the cavity.In at least one example embodiment, access to the controls portion(e.g., configured to house or otherwise contain the motor controller,CPU or processor(s), electronics, and/or wiring) may be provided via asecurely fastened panel of the housing 204, and/or panel separate fromthe access panel 224.

In at least one example embodiment, the apheresis system 200 may includea number of pumps 208, 212, 216 configured to control the flow of fluid(e.g., blood and/or blood components, anticoagulant, and/or saline)through the apheresis system 200. For instance, the apheresis system 200may include a draw pump 208 that controls blood flow to and/or from thedonor 102 into the centrifuge of the apheresis system 200. The draw pump208 may engage with a portion of the loop inlet tubing 108B disposedbetween the soft cassette assembly 300 and the centrifuge of theapheresis system 200. In at least one example embodiment, the apheresissystem 200 may include a return pump 212 configured to control a flow ofseparated blood components (e.g., plasma) from the centrifuge to aplasma collection bottle 122 and/or vice versa. Additionally, oralternatively, the return pump 212 may control a flow of saline (e.g.,supplied from a saline bag 118) throughout the blood componentcollection set and/or apheresis system 200. The anticoagulant pump 216may engage with a portion of the anticoagulant tubing 110 to selectivelycontrol the flow of anticoagulant throughout the blood componentcollection set of the apheresis system 200. As illustrated in FIG. 2A,the pumps 208, 212, 216 may be disposed at least partially on a topcover 210 of the apheresis system 200.

FIGS. 2B and 2C show various perspective views of a pump 208, 212, 216of the apheresis system 200 in accordance with at least one exampleembodiment of the present disclosure. Although the draw pump 208 isillustrated and described in conjunction with FIGS. 2B and 2C, it shouldbe appreciated that the other pump assemblies of the apheresis system200 (i.e., the return pump 212 and the anticoagulant pump 216) mayinclude a substantially similar, if not identical, construction to thedraw pump 208 described.

The draw pump 208 may include a pump cover 236 or housing configured toat least partially enclose the moving elements of the draw pump 208. Inat least one example embodiment, the pump cover 236 may include a hingedtubing guard 240 that is configured to open and close about a tubingguard pivot axis 242. In at least one example embodiment, the tubingguard 240 may be attached to the pump cover 236 via one or morefasteners disposed along the tubing guard pivot axis 242. As illustratedin FIGS. 2B and 2C, blood provided by a donor 102 may be conveyed, ordrawn, by the draw pump 208 into a centrifuge in a first draw orcentrifuge direction 250A. Additionally, or alternatively, blood orother fluid may be conveyed, or drawn, by the draw pump 208 toward thedonor 102 in a donor direction 250B, opposite the centrifuge direction250A.

In at least one example embodiment, the draw pump 208 and/or other pumps212, 216 may be a tubing pump, peristaltic pump, diaphragm pump, and/orother pump configured to manipulate the flow of fluid (e.g., blood,blood components, anticoagulant, and/or saline) in at least a portion oftubing. For example, the pumps 208, 212, 216 may include a motoroperatively interconnected with a rotating tubing contact assembly. Inoperation, the tubing (e.g., loop inlet tubing 108B, loop exit tubing112, and/or anticoagulant tubing 110) may be inserted into a lead tubingguide 244, a tubing pressure block 248, and an end tubing guide 252adjacent to the rotating tubing contact head. In at least one exampleembodiment, the tubing pressure block 248 may be moved in a directionaway from the rotating tubing contact head or pump 208, 212, 216providing a loading clearance area, or vice versa. The rotating tubingcontact head may include a number of rotary pressure rollers 268configured to rotate about respective pressure roller rotation axes 264.Each of the rotary pressure rollers 268 may be disposed between a firstrotary pump plate 272A and a second rotary pump plate 272B, where theplates 272A, 272B are configured to rotate about a pump rotation axis260. In at least one example embodiment, the rotary pressure rollers 268may be disposed at a periphery of the rotating pump plates 272A, 272B.

The one or more of the pumps 208, 212, 216 may include, or operatesimilarly to, the Pulsafeeder® model UX-74130 peristaltic pump,Pulsafeeder® MEC-O-MATIC series of pumps, all manufactured byPulsafeeder Inc., of Punta Gorda, Florida, without limitation. Otherexamples of pumps 208, 212, 216 may include, but are in no way limitedto, the INTEGRA DOSE IT laboratory peristaltic pump manufactured byINTEGRA Biosciences AG, of Switzerland, and WELCO WP1200, WP1100,WP1000, WPX1, and/or WPM series of peristaltic pumps all manufactured byWELCO Co., Ltd., of Tokyo, Japan.

Once the tubing is loaded into the lead tubing guide 244, the tubingpressure block 248, and/or the end tubing guide 252, at least some ofthe rotary pressure rollers 268 may be caused to engage with, contact,or otherwise compress the tubing disposed between the rotating tubingcontact head and the tubing pressure block 248. As the rotary pumpplates 272A, 272B rotate about the pump rotation axis 260 the rotarypressure rollers 268 may compress a portion of the tubing between thepump 208, 212, 216 and the tubing pressure block 248 positivelydisplacing fluid inside the portion of the tubing in a particulardirection 250A, 250B as the rotary pressure rollers 268 move. Forinstance, as the rotary pump plates 272A, 272B rotate in acounterclockwise direction about the pump rotation axis 260, therotation of the rotary pressure rollers 268 compressing the tubingbetween the rotary pressure rollers 268 and the tubing pressure block248 may displace, or pump, fluid in the centrifuge direction 250A. Asanother example, as the rotary pump plates 272A, 272B rotate in aclockwise direction about the pump rotation axis 260, the rotation ofthe rotary pressure rollers 268 compressing the tubing between therotary pressure rollers 268 and the tubing pressure block 248 maydisplace, or pump, fluid in the donor direction 250B. When not activelypumping, the pump 208 may be maintained in a state where at least onerotary pressure roller 268 continues to occlude the tubing 108B or in astate where no rotary pressure roller 268 occludes the tubing 108B.Thus, the pump 208, based on the state when motionless, can also act asa “valve” to prevent or allow fluid movement. This ability may also beavailable with pumps 212 and 216.

The tubing guard 240 and the pump cover 236 may serve to protect anoperator (e.g., phlebotomist and/or apheresis technician) and/or donor102 from incidental contact with one or more moving parts of the pumps208, 212, 216. In at least one example embodiment, the tubing guard 240may be held in a closed position via one or more guard closure features254 disposed in the tubing guard 240, the lead tubing guide 244, tubingpressure block 248, and/or the end tubing guide 252. In some cases,these guard closure features 254 may be magnets contained in the tubingguard 240, the lead tubing guide 244, tubing pressure block 248, and/orthe end tubing guide 252. In at least one example embodiment, the pump208, 212, 216 may be stopped or prevented from moving/operating when thetubing guard 240 is open. In at least one example embodiment, a guardclosed sensor may be included in the guard closure feature 254, theguides 244, 252, and/or the tubing pressure block 248.

One or more fluid control valves may be used to control the routing orflow direction of fluid conveyed throughout the tubing of the apheresissystem 200. In at least one example embodiment, the apheresis system 200may include a plasma and saline valve control system 228 disposedadjacent to the saline bag 118 and/or the plasma collection bottle 122.The plasma and saline valve control system 228 is illustrated in thedetail perspective view of FIG. 2D.

As illustrated in FIG. 2D, the loop exit tubing 112 may pass through thereturn pump 212 and interconnect with a saline and plasma tubingy-connector 280. The saline and plasma tubing y-connector 280 may allowconnection of the loop exit tubing 112 to a saline tubing 116 line and aplasma tubing 120 line. The plasma and saline valve control system 228may include an air detection sensor 284 disposed at a first end of thesaline and plasma valve housing 276 and surrounding a portion of theloop exit tubing 112. For example, the air detection sensor 284 may beany light, ultrasonic, or other type of sensor that can detect thepresence of fluid or air in the loop exit tubing 112 and provide thatsignal to a controller of the apheresis system 200. Types of airdetection sensors 284 may include, for example, the SONOCHECK ABD05,made by SONOTEC US Inc., or another similar sensor.

The saline and plasma valve housing 276 may include a number ofreceiving features (e.g., grooves, channels, and/or receptacles) thatreceive a portion of tubing 112, 116, 120, and/or the saline and plasmatubing y-connector 280. Upon detecting air in the loop exit tubing 112,the plasma and saline valve control system 228 may selectively actuateone or more of the fluid control valves 286, 288. In at least oneexample embodiment, the detection of air via the air detection sensor284 may be used to signal an operation step and/or trigger a step in acontrol method as described herein.

The plasma flow control valve 286 and/or the saline flow control valve288 may be a solenoid valve, linear actuator, pinch valve, clamp valve,tubing valve, and/or other actuatable valve configured to selectivelyalter (e.g., occlude) a fluid passage associated with a particularportion of tubing 112, 116, 120. As illustrated in FIG. 2D, the plasmaflow control valve 286 may be configured to pinch a portion of theplasma tubing 120 at least partially contained in a receiving feature ofthe saline and plasma valve housing 276. The saline flow control valve288 may be configured to pinch a portion of the saline tubing 116 atleast partially contained in a receiving feature of the saline andplasma valve housing 276. In any event, the control valves 286, 288 mayinclude an actuatable extendable finger that moves from a retracted, orpartially retracted, position to an extended, or partially extended,position to pinch the portion of tubing contained in the saline andplasma valve housing 276. While the control valves 286, 288 maycompletely pinch the tubing (e.g., completely restricting fluid flowtherethrough), it should be appreciated that the control valves 286, 288may be partially actuated to a position that partially restricts fluidflow through a portion of the tubing.

FIG. 3A illustrates an example disposable soft cassette assembly 300 inaccordance with at least one example embodiment of the presentdisclosure. The soft cassette assembly 300 may include a baseplate and acassette access door 304 that is attached to the baseplate via at leastone hinge and/or cassette access door latch 308. In at least one exampleembodiment, the cassette access door 304 may be unlocked via actuatingthe cassette access door latch 308 and pivoted about a cassette accessdoor hinge axis 306. The soft cassette assembly 300 may be configuredwith one or more soft cassette receiving features 324 for at leastpartially containing and/or locating a soft cassette 340 therein. Thesoft cassette 340 may be a part of the blood component collection setdescribed herein. For instance, the soft cassette 340 may be disposedbetween the cassette inlet tubing 108A and the loop inlet tubing 108B ofthe extracorporeal tubing circuit. In at least one example embodiment,the soft cassette 340 may provide one or more features for controllingthe flow of blood and/or blood components from a donor 102 to theapheresis system 200, and/or vice versa.

The soft cassette assembly 300 may include an air detection sensor 312,a fluid sensor 316, and one or more fluid control valves 320A-Cconfigured to control a routing or flow direction of fluid through thesoft cassette 340. In at least one example embodiment, these componentsmay be embedded in the cassette access door 304, the baseplate, and/or aportion of the housing 204 of the apheresis system 200. Similar to theguard closure feature 254 described in conjunction with FIGS. 2B-2C, thesoft cassette assembly 300 may include one or more door closure features328. These features 328 may include, but are not limited to, magneticcatches, protrusions, tabs and slots, and/or other connections. In atleast one example embodiment, the door closure features 328 may includepressure contact surfaces configured to hold or at least partiallyposition a soft cassette 340 inside the soft cassette assembly 300.

Examples of the valves 320A-C may include, but are in no way limited to,a solenoid valve, linear actuator, pinch valve, clamp valve, tubingvalve, and/or other actuatable valve configured to selectively alter(e.g., occlude) a fluid passage (e.g., cross-sectional area) associatedwith a particular portion of the soft cassette 340. The soft cassetteassembly 300 may include a first fluid control valve 320A configured topinch a portion of the soft cassette 340 adjacent to a cassette inlettubing 108A. The second fluid control valve 320B may be configured topinch a portion of the soft cassette 340 adjacent to the loop inlettubing 108B. A draw fluid control valve 320C may be configured to pincha portion of the soft cassette 340 along a branch tubing extending froma point adjacent to the cassette inlet tubing 108A to a point adjacentto the loop inlet tubing 108B. In any event, the valves 320A-C mayinclude an actuatable extendable finger that moves from a retracted, orpartially retracted, position to an extended, or partially extended,position to pinch the portion of the soft cassette 340 contained in thesoft cassette assembly 300. While the valves 320A-C may completely pinchflow paths in the soft cassette 340 (e.g., completely restricting fluidflow therethrough), it should be appreciated that the valves 320A-C maybe partially actuated to a position that partially restricts fluid flowthrough a portion of the soft cassette 340.

The sensors 312, 316 may be one or more of an ultrasonic detector,pressure sensor, magnetic position sensor, and/or the like. In somecases, the fluid sensor 316 may determine whether fluid is present inthe soft cassette 340 based on a position of a magnet relative to aportion of the soft cassette 340. For instance, when the portion of thesoft cassette 340 is filled with a fluid, the magnet may be disposed ata first position from a surface of the soft cassette 340. On the otherhand, when the portion of the soft cassette 340 is filled with air, theforce from the magnet may compress the portion of the soft cassette 340to a second position closer to the surface of the soft cassette 340 thanthe first position. In any event, the detection of air or fluid via theair detection sensor 312 and the fluid sensor 316, respectively, may beused to signal an operation step and/or trigger a step in a controlmethod as described herein.

FIGS. 3B-3D illustrates an example soft cassette 340 in accordance withat least one example embodiment of the present disclosure. As providedabove, the soft cassette 340 may be part of the blood componentcollection set. For instance, the soft cassette 340 may be a disposablecomponent used in the blood separation methods described herein. In atleast one example embodiment, the soft cassette 340 may be made from asubstantially compliant and/or flexible material. The compliant materialmay be chemically inert and/or be capable of withstanding sterilizationand cleaning operations, temperatures, and/or treatments. The softcassette 340 may be made from polyvinyl chloride (PVC), plasticized-PVC,polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone,thermoplastics, thermoplastic elastomer, polymers, copolymers, and/orcombinations thereof. In at least one example embodiment, the softcassette 340 may be molded, rotomolded, cast, injection molded, orotherwise formed from one or more of the materials described above.

The soft cassette 340 may include a first cassette port 360A, a secondcassette port 360B, and a direct flow lumen 370 running between thefirst and second cassette ports 360A-B. In at least one exampleembodiment, the first and/or second cassette ports 360A-B may beconfigured to receive and/or fluidly couple with one or more tubes ofthe blood component collection set. For example, the first cassette port360A may couple with the cassette inlet tubing 108A and the secondcassette port 360B may couple with the loop inlet tubing 108B. Thesecouplings may be air and/or fluid tight. In at least one exampleembodiment, the first and/or second cassette ports 360A-360B may includean aperture disposed within the soft cassette 340 that is configured toelastically stretch around an end of the tubing (e.g., cassette inlettubing 108A and/or loop inlet tubing 108B).

Blood supplied by the donor 102 may be directed along one or more fluidpaths disposed within the soft cassette 340. In at least one exampleembodiment, the blood may be directed along the direct flow lumen 370from the first cassette port 360A to the second cassette port 360B. Inat least one example embodiment, this flow path may direct the bloodthrough the drip chamber 354 of the soft cassette 340. In at least oneexample embodiment, blood and/or other fluids returned to the donor 102may be directed along the direct flow lumen 370 from the second cassetteport 360B to the first cassette port 360A.

The soft cassette 340 may include a fluid flow bypass path provided by afirst bypass branch 358A having a bypass flow lumen 364 that is fluidlyconnected to a portion of the direct flow lumen 370 adjacent to thefirst cassette port 360A or as part of the first cassette port 360A. Inat least one example embodiment, the bypass flow lumen 364 may run froma point of the direct flow lumen 370 adjacent to the first cassette port360A, along the first bypass branch 358A, through a fluid pressureannulus 362 to a second bypass branch 358B and reconnect to the directflow lumen 370 at a point adjacent to the second cassette port 360B oras part of the second cassette port 360B. As the name suggests, thebypass flow lumen 364 provides a flow path within the soft cassette 340that bypasses the drip chamber 354.

Controlling the flow path, or directing fluid, within the soft cassette340 may include actuating the fluid control valves 320A-C of the softcassette assembly 300 to interact with various compliant regions 350A-Cblocking and/or opening portions of the direct flow lumen 370 and/orbypass flow lumen 364. The first compliant region 350A provides a pinchvalve area at a point along the direct flow lumen 370 between the firstcassette port 360A and the drip chamber 354 near a first cassette end342 of the soft cassette 340. When the first fluid control valve 320A isactuated, the valve 320A may pinch the direct flow lumen 370 closed atthis first compliant region 350A, restricting or completely preventingthe flow of fluid at this point in the soft cassette 340. The secondcompliant region 350B provides a pinch valve area at a point along thedirect flow lumen 370 between the second cassette port 360B and the dripchamber 354 near a second cassette end 346 (e.g., opposite the firstcassette end 342). When the second fluid control valve 320B is actuated,the valve 320B may pinch the direct flow lumen 370 closed at this secondcompliant region 350B, restricting or completely preventing the flow offluid at this point in the soft cassette 340. As can be appreciated, thethird compliant region 350C disposed along the first bypass branch 358Aadjacent to the fluid pressure annulus 362 may provide a pinch valvearea at a point along the bypass flow lumen 364. When the draw fluidcontrol valve 320C is actuated, the valve 320C may pinch the bypass flowlumen 364 closed at this third compliant region 350C, restricting orcompletely preventing the flow of fluid through the bypass flow lumen364.

As illustrated in the elevation section view of FIG. 3C, taken through aplane running through the direct flow lumen 370 and drip chamber 354,the direct flow lumen 370 runs from the first cassette port 360A throughthe inner chamber volume 374 of the drip chamber 354 to the secondcassette port 360B. The direct flow lumen 370 may be formed as a fluidpassage running inside the first tubing section 368A, the inner chambervolume 374, and the second tubing section 368B of the soft cassette 340.

In at least one example embodiment, the bypass path of the soft cassette340 may include a fluid pressure annulus 362 through which fluid canflow from the first bypass branch 358A to the second bypass branch 358B,and/or vice versa. In at least one example embodiment, a pressurediaphragm 380 may be formed in the material of the soft cassette 340 anarea within, or adjacent to, the fluid pressure annulus 362. The fluidpressure annulus 362 and pressure diaphragm 380 are illustrated in theelevation section view of FIG. 3D taken through a plane running throughthe fluid pressure annulus 362 and a portion of the first and secondbypass branches 358A-B. The pressure diaphragm 380 may provide acontact, or measurement, surface for the fluid sensor 316 to detectwhether the fluid pressure annulus 362 and/or the bypass flow lumen 364includes an amount of fluid, air, and/or combinations thereof. Asprovided above, as fluid fills a portion of the fluid pressure annulus362, the fluid may provide greater resistance to movement than when thefluid pressure annulus 362 is filled with air. This difference inresistance may be measured via the fluid sensor 316 to determine, amongother things, an amount and/or type of fluid (e.g., air and/or blood) inthe bypass flow lumen 364 and/or the fluid pressure annulus 362.

FIGS. 4A-4C illustrate an example centrifuge assembly 400 for use withthe apheresis system 200 in accordance with at least one exampleembodiment of the present disclosure. The centrifuge assembly 400 may bedisposed in an interior space of the apheresis system 200. The interiorspace may be at least partially enclosed with one or more elements ofthe housing 204 and/or centrifuge chamber. Access to the interior spaceand the centrifuge assembly 400 may be provided via the access panel 224disposed at the front 202 of the apheresis system 200. For example, theaccess panel 224 of FIG. 4A is shown in an open position, opened alonghinged axis 226. As provided above, the hinged axis 226 may correspondto a door hinge, continuous hinge, cleanroom hinge, and/or some otherpanel hinge.

The centrifuge assembly 400 may be operatively mounted inside theapheresis system 200 such that the assembly 400 is capable of rotatingrelative to the housing 204 and/or other elements of the apheresissystem 200. The centrifuge assembly 400 may be loaded with one or moreportions of the blood component collection set by routing tubing (e.g.,loop inlet tubing 108B and/or loop exit tubing 112) into the interiorspace of the apheresis system 200 (e.g., via the opening 220 illustratedin FIG. 2A), connecting a portion of the blood component collection loop520 to the fixed loop connection 402 and inserting the blood componentseparation bladder 536 into a filler 460. The fixed loop connection 402maintains the loop inlet tubing 108B and the loop exit tubing 112 in afixed position and may prevent twisting of the tubing 108B, 112 outsideof the apheresis system 200. In at least one example embodiment, theblood component collection loop 520 may be interconnected to the fixedloop connection 402 via one or more keyed features or positive locationfeatures.

The centrifuge assembly 400 may include a centrifuge split-housing 404including a lower housing 404A pivotally connected to an upper housing404B. The upper housing 404B may open to provide access for loading ablood component separation bladder or other component of the bloodcomponent collection set into the centrifuge assembly 400. In at leastone example embodiment, the upper housing 404B may pivot about thesplit-housing pivot axis 406 (e.g., configured as a hinge, pin,fastener, and/or shoulder bolt).

The different halves (e.g., the lower housing 404A and upper housing404B) of the centrifuge split-housing 404 may be configured to lockand/or unlock together. Unlocking the upper housing 404B from the lowerhousing 404A may provide access to an interior of the centrifugeassembly 400. This selective locking may be achieved by rotating theupper housing 404B relative to the lower housing 404A about thecentrifuge rotation axis 430. Although the centrifuge split-housing 404is shown in FIGS. 4B-4C in an unlocked state, it should be appreciatedthat the upper housing 404B may be rotated (e.g., in a counterclockwisedirection) about the centrifuge rotation axis 430 to engage one or morelocking tabs 428 or elements of the upper housing 404B with lockingslots 432 disposed in the lower housing 404A (as illustrated in FIG.4C). When in the unlocked position, the upper housing 404B may beopened, or pivoted, about the split-housing pivot axis 406 to load thecentrifuge assembly 400 with a blood component collection loop 520and/or a blood component separation bladder 536. When in the lockedposition, the upper housing 404B is rotationally locked relative to thelower housing 404A, and the two halves of the centrifuge split-housing404 may spin together, locked in unison, during a centrifuge or bloodseparation operation.

The centrifuge assembly 400 may include at least one clockwise rotationstop 408A, counterclockwise rotation stop 408B, upper housing clockwiserotation flag 410A, and/or upper housing counterclockwise rotation flag410B. In at least one example embodiment, the rotation stops 408A, 408Bmay be rotationally fixed relative to the centrifuge rotation axis 430of the lower housing 404A. The rotation flags 410A, 410B may beattached, or formed in, the upper housing 404B and configured to contactrespective rotation stops 408A, 408B to prevent over-rotation of theupper housing 404B relative to the lower housing 404A when lockingand/or unlocking the two halves of the centrifuge split-housing 404together. For instance, upon rotating the upper housing 404B in aclockwise, or unlocking, direction about the centrifuge rotation axis430, a portion of the upper housing clockwise rotation flag 410A maycontact the clockwise rotation stop 408A preventing further rotation inthe clockwise direction. Additionally, or alternatively, upon rotatingthe upper housing 404B in a counterclockwise, or locking, directionabout the centrifuge rotation axis 430, a portion of the upper housingcounterclockwise rotation flag 410B may contact the counterclockwiserotation stop 408B preventing further rotation in the counterclockwisedirection. In at least one example embodiment, the centrifugesplit-housing 404 may include one or more locking elements configured tomaintain the halves of the centrifuge split-housing 404 in a lockedstate, while the locking elements are engaged.

In at least one example embodiment, the centrifuge split-housing 404 mayinclude a pull ring 412 attached to a portion of the upper housing 404Bto pivot the upper housing 404B relative to the lower housing 404A aboutthe split-housing pivot axis 406. The pull ring 412 may provide anaperture, through which a user may insert a finger and apply a pullforce to a rotationally unlocked upper housing 404B.

The centrifuge assembly 400 may include a rotor and motor assembly 414that is controlled and/or powered via electrically interconnectedelectrical cabling 420. The electrical cabling 420 may include aconnector that attaches to a controller, processor, and/or power supply.This electrical cabling 420 may convey power and/or data signals betweenthe rotor and motor assembly 414 and one or more controllers/processorsof the apheresis system 200. The rotor and motor assembly 414 may beconfigured as an electric motor and/or portions of an electric motorthat rotate the complete centrifuge assembly 400 relative to theapheresis system 200 (e.g., relative to a portion of the housing 204and/or base of the apheresis system 200). In other words, the rotor andmotor assembly 414 may include one or more components that cause thecentrifuge assembly 400 (e.g., both halves of the centrifugesplit-housing 404 together) to rotate inside the apheresis system 200.

As described herein, the centrifuge assembly 400 may include one or morefeatures to guide, contain, and/or position elements of the bloodcomponent collection set relative to the centrifuge split-housing 404.For instance, in FIG. 4B, the blood component collection loop 520 isillustrated as captured in an operational position in a loop rotationalposition guide 424 including a loop capture arm 416. The loop rotationalposition guide 424 may include a number of bearings 417, and/or bearingsurfaces, arranged to at least partially support the blood componentcollection loop 520 in an operational position. In the operationalposition, the blood component collection loop 520 may twist along itslength within the support provided by the bearings 417 of the looprotational position guide 424. For example, the blood componentcollection loop 520 may be fixedly attached at one end to the fixed loopconnection 402 of the apheresis system 200 while the other end of theblood component collection loop 520 may be attached to a filler 460(e.g., the inner rotating component of the centrifuge assembly 400). Asthe centrifuge assembly 400 spins during a centrifuge operation, thetwisting of the blood component collection loop 520 between the fixedloop connection 402 and the connection at the filler 460 may cause thefiller 460 to rotate relative to the centrifuge split-housing 404 of thecentrifuge assembly 400. In at least one example embodiment, the lowinertia of the filler 460 coupled with the twisting of the bloodcomponent collection loop 520 as the centrifuge assembly 400 rotates inthe apheresis system 200, may cause the filler 460 to rotate at twotimes the angular velocity of the centrifuge split-housing 404 in thesame direction of spin. In this example, when the centrifugesplit-housing 404 spins in a counterclockwise direction about thecentrifuge rotation axis 430 at a first angular velocity, 1ω, the filler460 may spin inside the centrifuge split-housing 404 in thecounterclockwise direction at a second angular velocity, 2ω (e.g.,substantially two times the first angular velocity).

The centrifuge assembly 400 may include one or more balancing features,elements, and/or structures disposed about the centrifuge rotation axis430 of the centrifuge assembly 400. These balancing features may providean axially balanced centrifuge assembly 400, such that when spun on thecentrifuge rotation axis 430, the centrifuge assembly 400 may impartsubstantially no vibration to the apheresis system 200. In at least oneexample embodiment, a centrifuge balance weight 418 may be attached to aportion of the centrifuge split-housing 404 (e.g., the lower housing404A and/or the upper housing 404B). This centrifuge balance weight 418may be custom tuned for the centrifuge assembly 400 and as such may beselectively attached and removed from the centrifuge assembly 400. Thetuning of the centrifuge balance weight 418 may be calculated and/orempirically derived to produce a completely balanced centrifuge assembly400, especially when loaded with one or more elements of the bloodcomponent collection set.

FIG. 4C is a rear perspective view of the centrifuge assembly 400. Aportion of the filler 460 is visible through an aperture in the upperhousing 404B. The blood component collection loop 520 is shown in aninitial loop loading position 520A, where a first end is interconnectedwith the filler 460 and a second end is fixedly attached to the fixedloop connection 402 (not shown). The blood component collection loop 520is shown as passing through a loop access clearance 436 in thecentrifuge split-housing 404. When the blood component collection loop520 is loaded in the loop loading position 520A a portion of the bloodcomponent collection loop 520 may be partially contained, held, and/orsupported by a loop containment bracket 426. The loop containmentbracket 426 may include one or more bearings 417 (e.g., roller bearings,ball bearings, needle bearings, and/or assemblies thereof), or bearingsurfaces, arranged to at least partially support the blood componentcollection loop 520 as it twists relative to the centrifuge assembly400. In at least one example embodiment, the blood component collectionloop 520 may rotate about an axis running along the length of theflexible loop 524 (e.g., in an installed or mounted condition and/orstate) allowing for relative rotational motion of the flexible loop 524to the loop rotational position guide 424. For instance, the loop doesnot “twist up” but actually rotates, or rolls, relative to the looprotational position guide 424 (e.g., support structure) in between oneor more bearings 417. This rotation or torsion, without binding ortwisting up the flexible loop 524, may be referred to herein as a twist.The twist allows the flexible loop 524 to transmit rotational force tothe filler 460 without a substantial reduction in the inside diameter ofthe lumen of the flexible loop 524. In some cases, there is no reductionin the inside diameter of the lumen of the flexible loop 524.

As described above, when the upper housing 404B is rotated from therotationally unlocked position as illustrated in FIGS. 4B-4C, to arotationally locked position, the locking tab 428 of the upper housing404B may engage with the locking slot 432 in the lower housing 404A.Additionally, or alternatively, when moved into the rotationally lockedposition, the loop containment bracket 426 may rotate, along with theblood component collection loop 520 and the upper housing 404B, to aposition in-line with the loop rotational position guide 424 along theloop engaged position 520B. In at least one example embodiment, the loopcapture arm 416 may guide the blood component collection loop 520 intothe bearings 417 and/or bearing surfaces of the loop rotational positionguide 424 as the upper housing 404B and the blood component collectionloop 520 rotate into the loop engaged position 520B. Further detailsregarding the loading of the blood component collection loop 520 aredescribed in conjunction with FIGS. 6A-7B.

FIGS. 4D-4F show various schematic section views taken through thecenter of the centrifuge assembly 400 (e.g., bisecting the centrifugeassembly 400 through the centrifuge rotation axis 430). As describedabove, the centrifuge assembly 400 may include a lower housing 404A thatis pivotally attached to an upper housing 404B by a split-housing pivotaxis 406, or hinge. The upper housing 404B may be attached to an upperhousing adapter 440 that is rotationally interconnected to the upperhousing bushing block 442 attached to the pull ring 412. In at least oneexample embodiment, a bearing 417, bushing, or bearing surface may bedisposed between the upper housing adapter 440 and the upper housingbushing block 442 allowing the upper housing 404B to rotate alongcentrifuge rotation axis 430 from a locked position into an unlockedposition, and vice versa. The pull ring 412 may be rotationally fixedabout centrifuge rotation axis 430 relative to the lower housing 404A.In at least one example embodiment, the upper housing adapter 440 andthe upper housing 404B may be formed from an integral structure.

The filler 460 may be fixedly attached to a filler mandrel 434 that isconfigured to rotate relative to the upper housing 404B about centrifugerotation axis 430. In at least one example embodiment, the fillermandrel 434 may be formed from a portion of the filler 460. In anyevent, one or more mandrel support bearings 444 may be disposed betweenthe filler mandrel 434 and the upper housing adapter 440 allowing thefiller 460 to rotate inside the centrifuge split-housing 404 andcentrifuge assembly 400 about the centrifuge rotation axis 430. In atleast one example embodiment, the filler mandrel 434 may be retained inan operative position via at least one retaining nut 438. The filler 460and filler mandrel 434 may spin together relative to the centrifugesplit-housing 404

FIG. 4D illustrates the centrifuge assembly 400 in a closed state (e.g.,prior to loading the blood component collection loop 520). Uponunlocking the upper housing 404B relative to the lower housing 404A, anoperator may pull on the pull ring 412 to pivot the entire upper housing404B and filler 460 about the split-housing pivot axis 406. In at leastone example embodiment, the upper housing 404B and the filler 460 may bepartially opened by pivoting the components about the split-housingpivot axis 406 in an opening direction 446 as illustrated in FIG. 4E. Asillustrated in FIG. 4E, where the centrifuge assembly 400 is illustratedin a partially opened state, the upper housing 404B and filler 460 arerotated out of axis from the lower housing rotation axis 430A. In thisposition, the filler 460 may be allowed to rotate about the fillerrotation axis 430B. When the lower housing 404A and upper housing 404Bare in a closed state, the lower housing rotation axis 430A and thefiller rotation axis 430B align (coincidentally, or substantiallycoincidentally) to form the centrifuge rotation axis 430.

Continuing to rotate the upper housing 404B and the filler 460 about theY-axis of the split-housing pivot axis 406 in the opening direction 446(e.g., by continuing to pull the pull ring 412) may cause the upperhousing 404B and the filler 460 to pivot substantially 180 degrees fromthe closed position shown in FIG. 4D. As illustrated in FIG. 4F, thecentrifuge assembly 400 is in an open, or loading, state. In thisposition, the upper housing 404B and the filler 460 may be pivotedoutside of the interior space of the apheresis system 200. For example,at least a portion of the upper housing 404B and/or the filler 460 maybe positioned through an open space of the opened access panel 224. Inthis position, a loading access area 450 may be provided to the loopconnection area 454 of the filler 460. As can be appreciated, orientingthe upper housing 404B in the open position provides easy access to theinterior of the upper housing 404B and the filler 460. Among otherthings, this arrangement may provide ample clearance for an operator toattach the blood component collection loop 520 to the filler 460 at theloop connection area 454.

FIG. 4G illustrates a filler 460, for example, the centrifuge assembly400. In at least one example embodiment, the filler 460 may be made froma lightweight material such as plastic, carbon fiber, and/or aluminum.In at least one example embodiment, the filler 460 may bethree-dimensionally (3D) printed via a 3D printing machine. Forinstance, the filler 460 may be produced via an additive manufacturingtechnique or system such as fused deposition modeling (FDM), selectivelaser sintering (SLS), stereolithography (SLA), and/or other additivemanufacturing machines. Among other things, these additive rapidprototyping manufacturing techniques can allow for more complexgeometries of the filler 460 that may not be possible through the use ofconventional machining or manufacturing processes. In at least oneexample embodiment, the material of the filler 460 may be selected basedon a desired mass of the filler 460, the desired physical strength ofthe manufactured filler 460, and/or suitable material for use inmanufacturing.

The filler 460 may include a loop connection area 454 disposedsubstantially at the center of the filler 460. The loop connection area454 may include one or more keying, or positive location, features for aportion of the blood component collection loop 520 to engage. Asillustrated in FIG. 4G, the loop connection area 454 includes a firstpositive location feature 478 disposed along a portion of the centeraxis of the filler 460. The first positive location feature 478 may be akeyway, groove, slot, or other feature for engaging with a matingfeature disposed on the blood component collection loop 520. In at leastone example embodiment, the filler 460 may include a second positivelocation feature 480 in the loop connection area 454. The locationfeatures 478, 480 may prevent rotation of the blood component collectionloop 520 at the loop connection area 454 and/or prevent the bloodcomponent collection loop 520 from disengaging from the loop connectionarea 454 of the filler 460.

In at least one example embodiment, the filler 460 may include aseparation insert channel 466 configured to receive, and at leastpartially contain, a blood component separation bladder of the bloodcomponent collection set and, more specifically, the blood componentcollection loop 520. The separation insert channel 466 may be configuredas a groove, slot, extending outwardly, in a substantially spiralfashion, from a center of the filler 460. In at least one exampleembodiment, the separation insert channel 466 may follow a substantiallyspiral shaped path that may include a first spiral path portionextending outwardly from the center of the filler 460 to a substantiallyconstant radius (e.g., about the center of the filler 460) along alength of the separation insert channel 466 periphery. In any event, thepath may be referred to herein as a spiral path or a substantiallyspiral path. The separation insert channel 466 may start at a channelentrance 468 adjacent to the center of the filler body 464 and terminateat a channel end 472 adjacent at a point furthest from the center of thefiller body 464. As illustrated in FIGS. 4G-4I, the separation insertchannel 466 may extend along a substantially spiral path 490 runningfrom a point adjacent to the filler rotation axis 430B to the channelend 472. The substantially spiral path 490 may include a channel pathjog 476 at a point near, or adjacent to, the channel end 472. Thischannel path jog 476 may extend the distance of the separation insertchannel 466 from the center of the filler body 464 thereby increasingthe centripetal and centrifugal forces at the channel end 472 of theseparation insert channel 466. In at least one example embodiment, thischannel path jog 476 may correspond to a critical inlet and exit port ata radial maximum within a blood component separation bladder 536 that isinserted or disposed, at least partially, within the separation insertchannel 466 of the filler 460. In at least one example embodiments, thefiller 460 may include one or more filler balance protrusions 482disposed on, in, or about a portion of the filler body 464. These fillerbalance protrusions 482 may provide an axially balanced (e.g., about thefiller rotation axis 430B) filler 460, especially when the separationinsert channel 466 includes a blood component separation bladder andfluid (e.g., blood, blood components).

FIG. 4I illustrates a substantially spiral-shaped receiving channel, orseparation insert channel 466, for a filler 460. The schematic plan viewshows a first distance, R1, of the separation insert channel 466 from acenter of the filler body 464 (e.g., adjacent to the filler rotationaxis 430B) at a first point along the substantially spiral path 490 anda second distance, R2, of the separation insert channel 466 from thecenter of the filler body 464 past a point adjacent to the channel pathjog 476. As illustrated in FIG. 4I, the second distance, R2, is furtherfrom the center of the filler body 464 than the first distance, R1. Thisincrease in distance may provide higher centripetal and centrifugalforces in the channel at a point near, or at, the channel end 472 thanat any other point along the substantially spiral path 490. In at leastone example embodiment, the end of the blood separation bladder maysubstantially coincide with the channel end 472, providing the greatestblood separation forces at the end of the bladder.

FIGS. 4J-4L show various elevation section of the filler 460 and, morespecifically of, the separation insert channel 466 and filler insertchamber 492 disposed inside the filler body 464. In at least one exampleembodiment, the separation insert channel 466 may include across-section, or shape, that substantially follows the substantiallyspiral path 490 in the filler body 464. The separation insert channel466 may include an insert groove configured to receive a substantiallyflat, or unfilled, blood component separation bladder. The bloodcomponent separation bladder may be inserted into the separation insertchannel 466 and a filler insert chamber 492 formed in the filler body464 along the substantially spiral path 490. The filler insert chamber492 may be defined by one or more sidewalls 494, 496 forming a cavitythat follows the substantially spiral path 490. As illustrated in FIG.4K, the filler insert chamber 492 includes an inner chamber wall 494separated a distance from at least one outer chamber wall 496. Thefiller insert chamber 492 may be formed in the filler 460 by 3D printingthe filler 460 and/or by some other metal or plastic forming operation,or operations (e.g., casting, molding, and/or forming). In at least oneexample embodiment, the filler insert chamber 492 may include one ormore insert guide features 498. These insert guide features 498 may beconfigured to guide, locate, and/or seat a blood component separationbladder inside the filler insert chamber 492 of the filler 460. Althoughshown as a chamfered, or lead-in, feature of the filler insert chamber492, the insert guide feature 498 may include one or more radius,chamfer, slope, taper, draft angle, receptacle, groove, and/or othershaped material configured to direct and/or orient a portion of aninserted blood component separation bladder.

FIG. 4L shows different states of fluid separation bladders (e.g., bloodcomponent separation bladders) disposed inside the separation insertchannel 466 and the filler insert chamber 492 of the filler 460. Asdescribed above, a blood component separation bladder may be insertedinto the separation insert channel 466 in a substantially flat, orunfilled, state, S1. In the substantially flat state, S1, the bloodcomponent separation bladder may be sized to enter the upper opening ofthe separation insert channel 466 and be maintained in a pre-fillcondition inside the filler insert chamber 492. When the filler 460begins to spin and separate blood components from blood provided by adonor 102, the blood component separation bladder may expand from thesubstantially flat first state, S1, to an expanded, or filled, state,S2. In at least one example embodiment, the blood component separationbladder may expand with blood and/or blood components until the walls ofthe blood component separation bladder contact the walls 494, 496 of thefiller insert chamber 492. In at least one example embodiment, the shapeof the filler insert chamber 492 may be designed to optimize the amountof fluid (e.g., maximize the volume of fluid while minimizing the amountof material for the filler 460) capable of being collected and/orseparated in the filler insert chamber 492.

FIG. 5A illustrates a blood component collection set 500 in accordancewith at least one example embodiment of the present disclosure. Theblood component collection set 500 may include the tubing (e.g., one ormore of the donor feed tubing 104, cassette inlet tubing 108A, loopinlet tubing 108B, anticoagulant tubing 110, loop exit tubing 112,saline tubing 116, and/or plasma tubing 120), the connectors (e.g., oneor more of the tubing connector 106, saline and plasma tubingy-connector 280, tubing fittings 504, tubing fitting 508, and/or bagspike fitting 512), soft cassette 340, and the blood componentcollection loop 520.

The tubing may include any tubing having a central lumen configured toconvey fluid therethrough. The tubing may be made from polyvinylchloride (PVC), plasticized-PVC, polyethylene, ethylene with vinylacetate (EVA), rubber, polymers, copolymers, and/or combinationsthereof. The connectors may be configured to fluidly interconnect withthe tubing (e.g., at one or more ends of the tubing). The connectors mayinsert into the central lumen of the tubing and/or attach to an outsideof the tubing. In at least one example embodiment, the connectors may beconfigured with various fittings (e.g., Luer fitting, twist-to-connect,and/or other small-bore couplings) to provide universal and/or reliableinterconnections to one or more other fittings, connectors, tubing,needles, and/or medical accessory. In at least one example embodiment,the bag spike fitting 512 may be configured to insert into a receivingbag (e.g., saline bag 118).

The blood component collection loop 520 may include a flexible loop 524disposed between a system static loop connector 528 and a filler loopconnector 532. The flexible loop 524 may be configured as a hollowflexible tube configured to receive and/or contain at least a portion ofthe loop inlet tubing 108B and the loop exit tubing 112. In at least oneexample embodiment, the flexible loop 524 may be made from athermoplastic elastomer having enhanced flexibility for transmittingtwist from one end of the flexible loop 524 to the other. These types ofelastomers may provide the flexibility of rubber while maintaining thestrength and torque characteristics of plastics. Examples of thethermoplastic elastomer may include, but are in no way limited to,copolyester, DuPont™ Hytrel® thermoplastic elastomers, Eastman Neostar™elastomers, Celanese Riteflex® elastomers, TOYOBO PELPRENE®, and/orother brand elastomers offering high flexibility and strengthcharacteristics.

In at least one example embodiment, the blood component collection loop520 may include a blood component separation bladder 536 having abladder loop end 540A and a bladder free end 540B. The blood componentseparation bladder 536 may include a first collection flow chamber 544connected to the flexible loop 524 at the filler loop connector 532. Inparticular, fluid may flow between the loop inlet tubing 108B and thefirst collection flow chamber 544 via the flexible loop 524 and theconnectors 528, 532, and/or vice versa. Fluid flowing in a directionfrom the bladder loop end 540A to the bladder free end 540B along thefirst collection flow chamber 544 may reach a flow chamber transition548 and enter the second collection flow chamber 552. In at least oneexample embodiment, the second collection flow chamber 552 isinterconnected to the flexible loop 524 at the filler loop connector532. In particular, fluid may flow between the loop exit tubing 112 andthe second collection flow chamber 552 via the flexible loop 524 and theconnectors 528, 532, and/or vice versa.

Details of the blood component collection loop 520 are illustrated inconjunction with the elevation view of FIG. 5B. The blood componentcollection loop 520 may include a flexible loop 524 configured as a tubeincluding a first pathway for the loop inlet tubing 108B and a secondpathway for the loop exit tubing 112. In at least one exampleembodiment, the loop inlet tubing 108B may pass through the flexibleloop 524 and interconnect with the first collection flow chamber 544 atthe bladder loop end 540A via the filler loop connector 532.Additionally, or alternatively, the loop exit tubing 112 may passthrough the flexible loop 524 and interconnect with the secondcollection flow chamber 552 at the bladder loop end 540A via the fillerloop connector 532. The first pathway is separate from the secondpathway. This configuration may allow blood to enter the flexible loop524 and the blood component separation bladder 536 via the firstcollection flow chamber 544 and separate into one or more bloodcomponents, which can then be conveyed along the second collection flowchamber 552 to the loop exit tubing 112 in the flexible loop 524.

The first collection flow chamber 544 may be separated from the secondcollection flow chamber 552 via a flow chamber separator 542. The flowchamber separator 542 may be a heat sealed portion of the bloodcomponent separation bladder 536. For example, the blood componentseparation bladder 536 may be made from layers of material overlappingone another along a length of the blood component separation bladder536. The layers of material may be shaped (e.g., cut or otherwiseshaped) and heat sealed along one or more edges forming a fluidcontainer. The flow chamber separator 542 may be formed in the fluidcontainer by heat sealing one layer of material to the other layer ofmaterial along a path as substantially illustrated. The flow chamberseparator 542 does not extend the complete length of the blood componentseparation bladder 536 providing a flow chamber transition 548 for fluid(e.g., blood, blood components) to pass from the first collection flowchamber 544 to the second collection flow chamber 552, and/or viceversa. In at least one example embodiment, fluid (e.g., blood and/orblood components) in the blood component separation bladder 536contained in the filler insert chamber 492 of the filler 460 may travelin a direction toward the bladder free end 540B along the firstcollection flow chamber 544 around an end of the flow chamber separator542 (e.g., following blood component movement direction 546) and intothe second collection flow chamber 552. In this example, bloodcomponents (e.g., plasma) may be forced back along the substantiallyspiral path 490 toward the center of the filler body 464 along thesecond collection flow chamber 552 and through the loop exit tubing 112(e.g., to a plasma collection bottle 122).

The blood component separation bladder 536 may be made from polyvinylchloride (PVC), plasticized-PVC, polyethylene, ethylene with vinylacetate (EVA), thermoplastics, thermoplastic elastomer, polymers,copolymers, and/or combinations thereof. In at least one exampleembodiment, the blood component separation bladder 536 may be formed,heat sealed from multiple layers of material, formed from a single layerof material folded onto itself, and/or combinations thereof.

In at least one example embodiment, the blood component collection loop520 may include a number of positive location, or key, features 530A,530B configured to positively locate portions of the blood componentcollection loop 520 relative to the apheresis system 200 and/or thefiller 460. For example, the blood component collection loop 520includes a first connector location feature 530A on the system staticloop connector 528 and a second connector location feature 530B on thefiller loop connector 532. The features 530A, 530B may be configured asa key, a tab, and/or other protrusion of material extending from theconnector 528, 532. In at least one example embodiment, the secondconnector location feature 530B may include features that interconnect,or mate, with the first positive location feature 478 and/or the secondpositive location feature 480 of the loop connection area 454 in thefiller 460. Similar, if not identical, positive location features may beassociated with, or included in, the fixed loop connection 402 of theapheresis system 200.

FIGS. 5C and 5D show cross-sections of the blood component separationbladder 536 of the blood component collection loop 520. For instance,the cross-sections show the first collection flow chamber 544 separatefrom the second collection flow chamber 552 along a length of the bloodcomponent separation bladder 536. In at least one example embodiment,the separation may be provided by a flow chamber separator 542 disposedbetween the first collection flow chamber 544 and the second collectionflow chamber 552. The flow chamber separator 542 may correspond to asealed region of the blood component separation bladder 536. The flowchamber separator 542 may be formed as a heat-sealed region of material,for instance, joining a bladder first side material 536A to a bladdersecond side material 536B. In some cases, the bladder first sidematerial 536A and the bladder second side material 536B may be a singlepiece of material folded at an edge (e.g., adjacent to one of the upperbladder seal 554A area or the lower bladder seal 554B area).

The cross-section shown in FIG. 5D may correspond to a blood componentseparation bladder 536 prior to sealing, and the cross-section shown inFIG. 5C may correspond to the blood component separation bladder 536after the upper bladder seal 554A, lower bladder seal 554B, and/or theflow chamber separator 542 are formed or sealed (e.g., welding thebladder first side material 536A to the bladder second side material536B). Once formed, the width of the bladder, WB, may correspond to thewidth of the first collection flow chamber 544 and/or the secondcollection flow chamber 552 in an unexpanded state, S1 (see, e.g., FIG.4L). During operation, as fluid fills at least a portion of the bloodcomponent separation bladder 536, the width of the bladder, WB, mayincrease in dimension from the dimension shown in FIG. 5C. For instance,the width of the bladder, WB, may increase substantially to the size ofthe filler insert chamber 492 of the filler 460. In at least one exampleembodiment, the welds (e.g., RF and/or ultrasonic) made whilemanufacturing the blood component separation bladder 536 may besupported in the filler 460. In at least one example embodiment, the topof the filler 460 supports the top two welds and the bottom of thefiller 460 supports a final weld.

FIGS. 5E-5H show various perspective views of the blood componentcollection loop 520 in a flexed state (e.g., FIGS. 5E-5F) as well asviews of the flexed blood component separation bladder 536 of the bloodcomponent collection loop 520 being inserting into a filler 460 (e.g.,FIGS. 5G-5H). The various components of the blood component collectionloop 520 may be flexible and/or capable of being formed or shaped by theapplication of force. In at least one example embodiment, thisflexibility may be elastic such that forming the various parts of theblood component collection loop 520 does not permanently deform thecomponents. FIG. 5E shows the blood component collection loop 520 in aflexed state. For example, the flexible loop 524 is shown elasticallybent along its length and the blood component separation bladder 536 isshown following a number of bends or curves along its length. Theflexible loop 524 may still convey fluids provided via the loop inlettubing 108B to the first collection flow chamber 544 of the bloodcomponent separation bladder 536, and vice versa, while the componentsare in a flexed state. Additionally, or alternatively, the flexible loop524 may convey fluids from the second collection flow chamber 552 of theblood component separation bladder 536 to the loop exit tubing 112, andvice versa, while the components are in the flexed state.

In at least one example embodiment, the blood component collection loop520 may be pre-formed, as illustrated in FIG. 5F, to fit inside theseparation insert channel 466 of a filler 460. This pre-forming mayinclude twisting the blood component separation bladder 536 of the bloodcomponent collection loop 520 to match the substantially spiral path 490of the separation insert channel 466. Once pre-formed, the features ofthe blood component collection loop 520 may be aligned with one or morefeatures of the filler 460, as illustrated in FIG. 5G. In at least oneexample embodiment, the filler loop connector 532 of the blood componentcollection loop 520 may be aligned with the loop connection area 454 ofthe filler 460 such that the second connector location feature 530B isaligned to engage with the first positive location feature 478.Additionally, or alternatively, the blood component separation bladder536 may be shaped, or formed (e.g., by hand), to match the substantiallyspiral path 490 of the separation insert channel 466 in the filler 460.In some cases, this shaping or forming may include aligning the bladderfree end 540B of the blood component separation bladder 536 with thechannel end 472 of the separation insert channel 466 in the filler 460.When the components are generally aligned with one another, the bloodcomponent collection loop 520 may be moved in a direction toward theseparation insert channel 466 and the loop connection area 454 (asillustrated in FIG. 5G).

In at least one example embodiment, when the filler loop connector 532is moved toward and into the loop connection area 454 of the filler 460,the first positive location feature 478 may interconnect and/or retainthe second connector location feature 530B of the filler loop connector532 of the blood component collection loop 520. This interconnection mayprevent the filler loop connector 532 from rotating relative to thefiller 460. In some cases, the interconnection may maintain the fillerloop connector 532 of the blood component collection loop 520 inside theloop connection area 454 of the filler 460. FIG. 5H shows the bloodcomponent collection loop 520 as loaded in the filler 460 in accordancewith at least one example embodiment of the present disclosure.

FIGS. 6A-6C illustrate a centrifuge assembly 400 in various loop-loadingstates in accordance with embodiments of the present disclosure. Thecentrifuge assembly 400 shown in FIGS. 6A-6C may correspond to thecentrifuge assembly 400 described above and especially in conjunctionwith FIGS. 4D-4F. In particular, FIG. 6A shows a schematic section viewof a first loop-loading state, FIG. 6B shows a schematic section view ofa second loop-loading state, and FIG. 6C shows a schematic section viewof a second loop-loading state for the centrifuge assembly 400.

In FIG. 6A, the centrifuge assembly 400 is shown in an open,loop-loading, position where the upper housing 404B has been pivoted 180degrees from a closed, or operational, position. This open position maycorrespond to the position of the centrifuge assembly 400 shown in FIG.4F. However, in FIG. 6A, a blood component collection loop 520 has beeninserted into the filler 460 and the filler loop connector 532 isinterconnected to the loop connection area 454 of the filler body 464.The other end of the blood component collection loop 520 is connected tothe fixed loop connection 402 via the system static loop connector 528.In this first loop-loading state, the flexible loop 524 is fixed fromrotating at the fixed loop connection 402 but rotates, in unison, withthe filler 460 at the loop connection area 454.

In FIG. 6B, the centrifuge assembly 400 is shown in a partially closedposition where the upper housing 404B is being moved from the openposition to a closed, or operational, position. As the upper housing404B pivots, the flexible loop 524 may move to a resting positionrelative to the centrifuge assembly 400. Although the flexible loop 524is rotationally fixed at the fixed loop connection 402, the filler 460may be free to rotate about the filler rotation axis 430B (e.g.,restricted only by the rotationally fixed flexible loop 524).

In FIG. 6C, the centrifuge assembly 400 is shown in a closed, oroperational, position where the upper housing 404B may be locked to thelower housing 404A (such that the lower housing 404A and the upperhousing 404B may rotate in unison about the centrifuge rotation axis430). In this position, the flexible loop 524 may pass from the loopconnection area 454 of the filler 460 through the loop access clearance436 of the centrifuge split-housing 404 to the fixed loop connection402. In at least one example embodiment, the flexible loop 524 may befree to move within the loop access clearance 436 with or withoutcontacting one or more portions of the centrifuge split-housing 404. Inthis position, as the centrifuge assembly 400 rotates about thecentrifuge rotation axis 430, the flexible loop 524 rotationally fixedat the fixed loop connection 402 may twist along the length of theflexible loop 524 thereby rotating the filler 460 inside the centrifugeassembly 400 (e.g., along the centrifuge rotation axis 430). As providedabove, the rotation of the filler 460 relative to the centrifugeassembly 400 may be at a 2:1 ratio. For instance, as the centrifugeassembly 400 rotates one revolution, the rotationally fixed flexibleloop 524 (e.g., fixed at the fixed loop connection 402) twists at theloop connection area 454 (e.g., trying to unravel from being twisted bythe rotation of the centrifuge assembly 400) thereby rotating the filler460 in the same rotational direction as the centrifuge assembly 400 butat substantially two revolutions. This rotation of the filler 460, bythe twisting of the flexible loop 524 along its length, requires nogearing between the centrifuge assembly 400 and the filler 460.

FIGS. 7A-7B show schematic plan views of the centrifuge assembly 400automatically loading a loop into an operational position (e.g., bloodseparation) for centrifuging. The centrifuge assembly 400 illustrated inFIGS. 7A-7B may correspond to the centrifuge assembly 400 as previouslydiscussed and/or as described in conjunction with FIGS. 4A-4F and FIGS.6A-6C. Once the blood component collection loop 520 has been loaded intothe centrifuge assembly 400, as illustrated in FIG. 6C, the flexibleloop 524 may be automatically loaded into a loop engaged position 520Bas illustrated in FIGS. 7A-7B.

In at least one example embodiment, when the upper housing 404B islocked to the lower housing 404A, the flexible loop 524 may run from theloop connection area 454 of the filler 460 to the fixed loop connection402 of the apheresis system 200. Although the flexible loop 524 may berotationally fixed to the fixed loop connection 402 at the system staticloop connector 528, the flexible loop 524 passing through the loopaccess clearance 436 in the centrifuge split-housing 404 may notinitially be held, or at least partially captured, by the looprotational position guide 424 and/or other features of the centrifugeassembly 400. This state of the flexible loop 524 relative to the looprotational position guide 424, or loop arm, may correspond to anuncaptured loop state 700A. In other words, the flexible loop 524 may beoriented at some angle, a, relative to the loop rotational positionguide 424, loop position stop plate 704, and/or one or more loop twistsupport bearings 708, or bearing sets. In at least one exampleembodiment, the loop twist support bearing 708 may correspond to thebearings 417 described in conjunction with FIGS. 4B-4C. A loopcontainment area, or channel, may be formed by the loop position stopplate 704, and/or one or more loop twist support bearings 708 disposedalong a length of the upper housing 404B. In at least one exampleembodiment, this orientation may be engineered to allow access and/orease of loading during the loop-loading described in conjunction withFIGS. 6A-6C.

As the centrifuge assembly 400 is rotated in a loop and filler rotationdirection 712 about centrifuge rotation axis 430, the flexible loop 524may move from the uncaptured loop state 700A to the captured loop state700B illustrated in FIG. 7B. This rotation may be caused by an operatorrotating the centrifuge assembly 400 and/or the filler 460 in the loopand filler rotation direction 712 and/or by the rotor and motor assembly414 causing the centrifuge assembly 400 to rotate about the centrifugerotation axis 430. In at least one example embodiment, as the flexibleloop 524 rotates in the loop and filler rotation direction 712, an outerportion of the flexible loop 524 may contact a loop position stop plate704, or other rotational stop surface, of the loop rotational positionguide 424.

While the flexible loop 524 is held, or at least partially contained, inthe loop rotational position guide 424, a portion of the flexible loop524 may move within one or more of the loop twist support bearings 708.As described above, the flexible loop 524 may be rotationally fixed tothe fixed loop connection 402 via the first connector location feature530A of the system static loop connector 528 associated with the bloodcomponent collection loop 520. This rotationally fixed connectionprevents the flexible loop 524 from rotating relative to the apheresissystem 200 at the fixed loop connection 402. The other end of theflexible loop 524 may be interconnected at the loop connection area 454of the filler 460 where the end can move with the filler 460 and/orcentrifuge assembly 400. As the centrifuge assembly 400 continues torotate in the loop and filler rotation direction 712, the forces fromthe flexible loop 524 attempting to unravel, or keep from binding,rotate the filler 460 and the end of the flexible loop 524 attachedthereto.

In any event, once the fluid separation methods described herein arecompleted, the centrifuge assembly 400 may be stopped from rotating andthe centrifuge split-housing 404 may be opened to remove the disposableelements of the blood component collection set 500 from the centrifugeassembly 400. In some cases, the flexible loop 524 may be moved from thecaptured loop state 700B shown in FIG. 7B to the uncaptured loop state700A shown in FIG. 7A by rotating the centrifuge assembly 400 and/or thefiller 460 in a direction opposite the loop and filler rotationdirection 712.

An example functional diagram of the apheresis system 200 is illustratein FIG. 8 . The description herein shows the components previouslydescribed, in FIGS. 1-7B, in a functional diagram to describe theoperation of the system 200 for extracting plasma or other bloodcomponents from the whole blood of a donor 102 during an apheresisprocedure or process.

The system 200 can include an anticoagulant (AC) pump 216. The AC pump216 pumps fluid in AC tubing 110 from the AC bag 114. The AC pump 216,the AC tubing 110, and/or the AC bag 114 may be as described previously.The AC tubing 110 may also include an AC air detection sensor (ADS) 804to detect air or fluid within the AC tubing 110. The AC ADS 804 may bethe same or similar in type and/or function to sensor 284 and/or sensor312, described previously. AC tubing 110 may intersect with and befluidly associated with the donor feed tubing 104 and the cassette inlettubing 108A at tubing connector 106. The tubing connector 106 may be anytype of connection between tubing 110, 104, and/or 108A, as describedpreviously.

The donor feed tubing 104 proceeds from the donor 102, where the donor102 may be stuck with a lumen needle or other device, allowing wholeblood to flow from the donor 102 into the apheresis system 200 andallowing blood components to flow back to the donor 102. Tubing 108A mayproceed to the soft cassette 340. Further, a donor air detection sensor312 may be placed on or in tubing 108A to detect the presence of fluidand/or air within tubing 108A.

As explained previously, the soft cassette 340 can include the firstcassette port 360A, which can function as, include, and/or besubstantially proximate to a “Y” connector or section, or branches, thatseparates the tubing 108A into the first bypass branch 358A and thefirst tubing section 368A (the “Y” section will be designated byreference character 360A). The two tubing sections 358 and 368 canreconnect at the second cassette port 360B, which can also function as,include, and/or be substantially proximate to a second “Y” connector orsection (the second “Y” section will be designated by referencecharacter 360B). Tubing 358 is bisected by the fluid sensor 316, whichseparates the tubing 358 into the first bypass branch 358A and thesecond bypass branch 358B. Likewise, tubing 368 is bisected by the dripchamber 354 that separates tubing 368 into a first tubing section 368Aand a second tubing section 368B.

The first tubing section 368A may include a first fluid control valve320A. The second tubing second 368B may include a second fluid controlvalve 320B. The first bypass branch 358A may include a draw fluidcontrol valve 320C. As such, the various sections of tubing 368A, 358A,358B, and 368B may be isolated by the valves 320A, 320B, and/or 320Cbased on the configuration of the system 200 and depending on theoperation of the system 200.

A drip chamber 354 may be disposed between the first tubing section 368Aand the second tubing section 368B. The drip chamber 354 can collect avolume of whole blood and/or high hematocrit blood (blood with a highpercentage of red blood cells) depending on the operation of the system200, as described hereinafter. The fluid sensor 316, as describedpreviously, may be disposed between the first bypass branch 358A and thesecond bypass branch 358B.

Loop inlet tubing 108B can connect to the second cassette port 360B andcan connect the soft cassette 340 to the flexible loop 524. The loopinlet tubing 108B may also include a sensor 808, disposed on or in thetubing 108B, placed with the tubing 108B before connecting with thesystem static loop connector 528 of the flexible loop 524. The pressuresensor (CPS) 808 may detect one or more of, but not limited to:pressure, presence of fluid or air, and/or possibly anothercharacteristic of the fluid in tube 108B. Further, a draw pump 208 cancause fluid to be pumped through tubing 108B either away from the softcassette 340 or to the soft cassette 340.

Two or more different tubes may be connected to the flexible loop 524through the system static loop connector 528 and provide fluid to, orreceive fluid from, the blood component separation bladder 536. A loopexit tubing 112 exits the system static loop connector 528 from flexibleloop 524. This loop exit tubing 112 can also include another line sensor812 disposed thereon or therein to detect fluid, air, cellularconcentration, color, and/or color change in the fluid coming from theflexible loop 524; the line sensor 812 may be the same or similar intype and/or function to sensors 804, 312, 320, 808, and/or 284previously described. A second CPS sensor 816 or fluid sensor may alsobe disposed in or on line 112. Sensor 816 may detect one or more of, butnot limited to: the presence or absence of fluid, pressure within tubing112, and/or other characteristic of the fluid in tubing 112. Sensor 816may be the same or similar in type and/or function to sensors 804, 312,320, 808, 812 and/or 284 previously described.

Loop exit tubing 112 may then flow into a plasma air detection sensor284 before the saline and plasma tubing y-connector 280 separates thetubing 112 into saline tubing 116 and plasma tubing 120. The return pump212 may interact with the loop exit tubing 112 and can cause fluid orair to flow through tubing 112 from either the flexible loop 524 or froma saline bag 118 and/or a plasma collection bottle 122.

The saline bag 118 and associated tubing, as previously described, mayprovide saline through the system 200 back to the donor 102. A salineflow control valve 288 may isolate the saline bag 118 from the rest ofthe system 200. Further, a plasma collection bottle 122 may receiveplasma from the flexible loop 524 when processed or separated from thewhole blood. The plasma collection bottle 122 may be selectivelyisolated from the system by the plasma flow control valve 286.

FIG. 9 illustrates an example electrical and control system 900controlling the functions of the apheresis system 200. The controlsystem 900 can include one or more nodes, which can include varioushardware, firmware, and/or software configured to control and/orcommunicate with the mechanical, electromechanical, and electricalcomponents of the apheresis system 200.

Each node may function to control a different part of the apheresissystem 200. For example, the control system 900 can include a cassettenode 904 and a centrifuge node 908, which may control or communicatewith the components of the blood component collection set 500 (and theassociated hardware or mechanical components interfacing with the softcassette assembly 300) and the centrifuge assembly 400 (and theassociated hardware or mechanical components associated therewith),respectively. The cassette node 904 and centrifuge node 908 may be incommunication either wirelessly or through some other electrical or dataconnection. In at least one example embodiment, the separate nodes 904,908 may be two portions of a single node 902. As such, each node 904,908 may have the same physical hardware operating to control differentfunctions. An example of the cassette node 904 may be as described inconjunction with FIG. 10 ; a centrifuge node 908 may be as described inconjunction with FIG. 11 .

Each of the nodes 904, 908 may be in communication with one or moresensors 916, 920, and/or 924. There may be more or fewer sensors thanthose illustrated in FIG. 9 , as represented by ellipsis 928. Each node904, 908 can communicate directly to each sensor 916-924 or maycommunicate with the several sensors 916-924 via a bus 912. The bus 912may communicate by any type of communication protocol, such as universalserial bus (USB), a universal asynchronous receive/transmit (UART), orother types of bus systems or parallel communication connections. Thus,the bus 912 may be optional, but is shown as a possible communicationplatform to communicate with the various sensors 916-924. The sensors916-924 may be any type of sensor that can communicate information aboutlight, fluid, the presence of air, color, and/or pressure. Some of thesensors 916-924 may include sensors 312, 316, 804, 808, 812, 816, and/or284. The function of these sensors 912-924 may be as describedhereinafter.

The nodes 904, 908 may also communicate with one or more pump drives,pump motors, 936, 940, 944, simply referred to as “pumps.” There may bemore or fewer pumps than as illustrated in FIG. 9 , as represented byellipsis 948. The nodes 904, 908 can communicate with the pumps 936-944through direct wired or wireless communication or through a bus 932. Thebus 932 may be a control area network (CAN) bus, USB, or other type ofbus architecture to communicate with the pumps 936-944. The pumps936-944 may include pumps 216, 208, and/or 212, as previously described.The function of the pumps 936-944 may be described as herein.

FIG. 10 illustrates an example cassette node 904. The cassette node 904can include one or more of a controller 1004, a memory 1008, a valvecontroller 1020, and/or communication interfaces for a CAN bus 1016, aUART 1012, or other types of buses. The cassette node 904 can includeother hardware, firmware, and/or software that are not shown forclarity.

The controller 1004 may be any type of microcontroller, microprocessor,Field Programmable Gate Array (FPGA), Application Specific IntegratedCircuit (ASIC), and/or the like. An example controller 1004 may be theNK10DN512VOK10 microcontroller, made and sold by N9P USA, Incorporated,which is a microcontroller unit with a 32-bit architecture. Other typesof controllers are possible. The controller 1004 may control other typesof devices or direct the functions of other types of devices, such asvalves 320A, 320B, 320C, 286, 288, pumps 936-944. Further, thecontroller 1004 may communicate with various sensors 916-924 or otherdevices to receive or send information regarding the function of theapheresis system 200.

Other examples of the processors or microcontrollers 1004, as describedherein, may include, but are not limited to, at least one of Qualcomm®Snapdragon® 800 and 801, Qualcomm® Snapdragon® 610 and 615 with 4G LTEIntegration and 64-bit computing, Apple® A7 processor with 64-bitarchitecture, Apple® M7 motion coprocessors, Samsung® Exynos® series,the Intel® Core™ family of processors, the Intel® Xeon® family ofprocessors, the Intel® Atom™ family of processors, the Intel Itanium®family of processors, Intel® Core® i5-4670K and i7-4770K 22 nm Haswell,Intel® Core® i5-3570K 22 nm Ivy Bridge, the AMD® FX™ family ofprocessors, AMD® FX-4300, FX-6300, and FX-8350 32 nm Vishera, AMD®Kaveri processors, ARM® Cortex™-M processors, ARM® Cortex-A andARM926EJ-S™ processors, other industry-equivalent processors, and mayperform computational functions using any known or future-developedstandard, instruction set, libraries, and/or architecture.

The memory 1008 may be any type of memory including random access memory(RAM), read only memory (ROM), electrically erasable programmable ROM(EEPROM), a portable compact disc read-only memory (CD-ROM), an opticalstorage device, a magnetic storage device, any suitable combination ofthe foregoing, or other type of storage or memory device that stores andprovides instructions to program and control the controller 1004. Thememory 1008 may provide all types of software or firmware that programsthe functions of the controller 1004, as described hereinafter.

The controller 1004 may communicate with one or more valve controllers1020. Each valve 320A, 320B, 320C, 286, 288, as described herein, may becontrolled by a valve controller 1020 and may be associated with acomponent of the system 200, as described herein. The valve controller1020 may provide the electrical signal, operational directive, or powerto close or open any one of the valves described herein, for example,the saline and plasma valve housing 276, the plasma flow control valve286, the saline flow control valve 288, the first fluid control valve320A, the first fluid control valve 320A, and/or the draw fluid controlvalve 320C.

The controller 1004 may be connected to a bus 912, 932 (e.g., UART busand/or CAN bus), or other busses through transceivers 1012, 1016provided outside of the controller 1004 or integral to the controller1004. The UART transceiver 1012 may communicate with one or more of thesensors 916-924 or other devices. Likewise, the CAN bus transceiver 1016may communicate with one or more of the pump controllers 936-944 orother devices. UART transceivers 1012 and busses and CAN bustransceivers 1016 and busses are well known in the art and need not beexplained further herein.

FIG. 11 illustrates an example centrifuge node 908. The centrifuge node908, may include the same or similar types of components as the cassettenode 904. For example, the centrifuge node 908 may include a controller1104 and/or a UART transceiver 1112. Similar to the controller 1004, thecontroller 1104 may be any type of processor or microcontroller, forexample the NK10DN512VOK10 microcontroller unit with 32-bit architecturefrom N9P USA, Incorporated, as mentioned previously, or othercontrollers, processors, for example, the devices mentioned previously.

The controller 1104 may communicate with the sensors 916-924 directly,through the UART transceiver 1112, or through other busses or systems.The controller 1104 may communicate with a brake controller 1124 thatmay brake or slow and stop the centrifuge 400. Likewise, a controller1104 may communicate with a motor transceiver 1116 that communicateswith a motor power system or a motor controller that functions to spinup or rotate the centrifuge 400 or control the speed setting or otherfunction of the centrifuge 400.

In at least one example embodiment, the controller 1104 may communicatewith a cuff controller 1122 that may change or set the pressure of apressure cuff on a donor's arm during the apheresis process. Further,the controller 1104 may communicate with and/or control a strobe 1112,which is any light that flashes at a periodicity in synchronicity withthe rate of spin of the motor, such that an operator of the apheresissystem 200 can see the operation of the filler 460, as describedpreviously. Thus, the controller 1104 may communicate with the strobe1112 to change the frequency of the flashing of the strobe light 1112and/or the intensity of the strobe light 1112.

FIG. 12 illustrates an example method 1200 used to complete bloodcomponent (e.g., plasma) apheresis, with the system 200, in accordancewith at least one example embodiment of the present disclosure. Themethod 1200 may be described in conjunction with FIGS. 17A-17T. As such,the method 1200 will be described in relation or with reference to thosefigures. A general order for the steps of the method 1200 is illustratedin FIG. 12 . Generally, the method 1200 starts with a start operation1204 and ends with operation 1220. The method 1200 may include more orfewer steps or may arrange the order of the steps differently than thoseillustrated in FIG. 12 . The method 1200 may be, at least partially,executed as a set of computer-executable instructions executed by acomputer system, processor, cassette microcontroller 1004, centrifugemicrocontroller 1104, and/or another device and encoded or stored on acomputer readable medium. In at least one example embodiment, the method1200 may be executed, at least partially, by a series of components,circuits, and/or gates created in a hardware device, such as a System onChip (SOC), Application Specific Integrated Circuit (ASIC), and/or aField Programmable Gate Array (FPGA). Hereinafter, the method 1200 shallbe explained with reference to the systems, devices, valves, pumps,sensors, components, circuits, modules, software, data structures,signaling processes, models, environments, and/or apheresis systems, forexample, as described in conjunction with FIGS. 1-11 .

The method 1200 may generally be separated into three phases, where eachphase includes a series of steps or processes. Each of the three phasesis described in FIG. 12 and with reference to FIGS. 13-16 , whichdescribe the steps or processes. The method 1200 may include a preparingthe system phase, in step 1208. In this phase 1208, the operator mayprepare the system 200 for apheresis, which might include steps to placethe needle in the donor 102, conduct other operations to prepare forblood draw, insert the blood component collection set 500 into thesystem. An example of the steps that may be included in the preparingthe system phase 1208 may be as described in conjunction with FIG. 13 .

The method 1200 may enter a draw plasma phase, in step 1212. The drawplasma phase 1212 may be as described in conjunction with FIG. 14 . Thedraw plasma phase 1212 may include the drawing of the blood,centrifuging of blood to extract plasma (and/or other blood components),pushing the high hematocrit blood (e.g., red blood cells), and/or otherblood components, back to the donor 102 in various return cycles (untila full sample of plasma and/or other blood component is collected). Thestart of the return cycles may be triggered based on the presence, atsome predetermined position in the apheresis system, of one or moreblood components (e.g., platelets and/or red blood cells)

The final phase of the method 1200 may be an unload disposable phase, instep 1216. The unload disposable phase 1216 may be described inconjunction with FIG. 15 . The unload disposable phase 1216 may includethe completion of the apheresis process, the removing of the needle fromthe donor 102, unloading the blood component collection set 500, andcompleting the procedure. Each of the three phases 1208-1216, and thesteps or process associated therewith, will now be describedhereinafter.

FIG. 13 illustrates an example method for prepping the apheresis system200, as described in phase 1208, in accordance with at least one exampleembodiment of the present disclosure. The method 1300 may start with astart operation 1304 and ends with operation 1328. The method 1300 mayinclude more or fewer steps or may arrange the order of the stepsdifferently than those shown in FIG. 13 . The method 1300 may be, atleast partially, executed as a set of computer-executable instructionsexecuted by a computer system, processor, cassette microcontroller 1004,centrifuge microcontroller 1104, and/or other devices and encoded orstored on a computer readable medium. In at least one exampleembodiment, the method 1300 may be executed, at least partially, by aseries of components, circuits, and/or gates created in a hardwaredevice, such as a SOC, ASIC, and/or a FPGA. Hereinafter, the method 1300shall be explained with reference to the systems, devices, valves,pumps, sensors, components, circuits, modules, software, datastructures, signaling processes, models, environments, apheresissystems, and/or methods, for example, as described in conjunction withFIGS. 1-12 .

A user, or operator, may load the blood component collection set 500, instep 1308. In this step 1308, the user may load the blood componentcollection set 500 into the system 200, including inserting the flexibleloop 524 into the loop containment bracket 426 and the blood componentseparation bladder 536 into the filler 460 (which may both be asdescribed in FIG. 16 ). Further, the soft cassette 340 may be mounted inthe soft cassette assembly 300, as described in conjunction with FIGS.1, 2A, 2B, 3A, and/or 3B. The loop inlet tubing 108B may be insertedinto the lead tubing guide 244 and/or end tubing guide 252 to the drawpump 208 to cause fluid movement in the loop inlet tubing 108B and otherparts of the blood component collection set 500. Similarly, theanticoagulant tubing 110 may be placed into tubing guides, similar toguides 244, 252, to allow the AC pump 216 to move anticoagulant into theanticoagulant tubing 110 or other parts of the blood componentcollection set 500. The loop exit tubing 112 may be inserted intosimilar guides 244, 252 to allow the return pump 212 to move bloodcomponents (e.g., plasma) into the plasma collection bottle 122 or movesaline from the saline bag 118 into the loop exit tubing 112 or otherportions of the blood component collection set 500.

As illustrated in FIG. 2D, the saline and plasma tubing y-connector 280may be mounted into a plasma and saline valve control system 228 toallow the valves 286, 288 to control fluid flow from and/or to theplasma collection bottle 122 and/or the saline bag 118. The AC bag 114may be mounted onto an anticoagulant support 232A, the plasma collectionbottle 122 may be placed in the plasma collection cradle 232C, and thesaline bag 118 may be mounted onto the saline support 232B, as describedin FIGS. 1-2B. With the blood component collection set 500 mounted inthe apheresis system 200, the apheresis system 200 may appear asillustrated in FIGS. 17A and 17B. The status of the various componentsof the apheresis system 200, during this step, may be as shown below:

TABLE 1 Load Kit Status Load Kit Status Flow Spin Rate Open/ RateComponent Name (mL/min) Occlude? Closed? (RPM) Draw pump 208 0 No Returnpump 212 0 No Anticoagulant pump 216 0 Plasma flow control valve 286Open Saline flow control valve 288 Open First fluid control valve 320AOpen Second fluid control valve Open 320B Draw fluid control valve 320COpen Filler 460 0

As shown in the above table and in subsequent tables, the draw pump 208and return pump 212 may occlude the loop inlet tubing 108B and theanticoagulant tubing 110, respectively. In this way, the draw pump 208and return pump 212 function as “valves” that selectively allow ordisallow fluid flow. A minus sign, “−”, in the “Flow Rate” columnrepresents that the pump is moving in a counterclockwise rotation. Theabbreviation “AF” means “Auto-flow” and represents that the pump isfunctioning at the flowrate of the blood coming from the donor 102. ThisAF flowrate prevents the apheresis system 200 from syphoning blood fromthe donor 102 or backing the flow of blood into the donor 102 and/or AFoptimizes draw and return flowrates while improving donor safety.

The saline bag 118 may be spiked, in step 1312. A user may remove anysafety coverings from a bag spike fitting 512, at the distal end of thesaline tubing 116, to puncture the saline bag 118, which contains thesaline. In at least one example embodiment, the saline tubing 116 may bemechanically attached to the saline bag 118 (e.g., by a Luer connector)and a frangible device or other removable barrier may be modified, by auser, to allow for the flow of saline from the saline bag 118. Thus,spiking the saline bag 118 allows saline to flow into the bloodcomponent collection set 500 to or through the saline flow control valve288. The status of the various components of the apheresis system 200,during this step, may be as shown below:

TABLE 2 Spike Saline Status Spike Saline Status Flow Spin Rate Open/Rate Component Name (mL/min) Occlude? Closed? (RPM) Draw pump 208 0 NoReturn pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve286 Closed Saline flow control valve 288 Closed First fluid controlvalve 320A Open Second fluid control valve Open 320B Draw fluid controlvalve 320C Open Filler 460 0

In step 1316, the saline 1712 is primed. Priming the saline 1712includes the cassette microcontroller 1004 directing the opening of thesaline flow control valve 288, as illustrated in FIG. 17D. The cassettemicrocontroller 1004 may receive instructions for a user interface orprogram to begin the apheresis process, which begins by priming thesaline 1712. Thus, the saline 1712 moves from the saline bag 118,through the saline flow control valve 288 to the plasma air detectionsensor 284. The cassette microcontroller 1004 directs thecounterclockwise rotation of the return pump 212 to cause the volumetricflow of saline 1712 from the saline bag 118 and through saline tubing116 and the saline and plasma tubing y-connector 280, mounted in theplasma and saline valve control system 228, to the plasma air detectionsensor 284. Upon the plasma air detection sensor 284 detecting eitherthe presence of liquid or the lack of air in the loop exit tubing 112, asignal is sent to the cassette microcontroller 1004. The cassettemicrocontroller 1004 may direct the return pump 212 to stop rotationsand direct the saline flow control valve 288 to close, which preventssaline 1712 from further entering the loop exit tubing 112 substantiallybeyond the plasma air detection sensor 284. At this point in theprocess, the apheresis system may appears as illustrated in FIG. 17E.The status of the various components of the apheresis system 200, duringthis step, may be as shown below:

TABLE 3 Prime Saline Status Prime Saline Status Flow Spin Rate Open/Rate Component Name (mL/min) Occlude? Closed? (RPM) Draw pump 208 0 NoReturn pump 212 −10 Yes Anticoagulant pump 216 0 Plasma flow controlvalve 286 Closed Saline flow control valve 288 Open First fluid controlvalve 320A Open Second fluid control valve Open 320B Draw fluid controlvalve 320C Open Filler 460 0

It should be noted that the return pump 212 is described as moving inthe counterclockwise rotation. This direction of rotation is associatedwith the location of the return pump 212 in relation to the loop exittubing 112. If the return pump 212 is mounted with the loop exit tubing112 below the return pump 212, the return pump 212 would rotate in theclockwise direction to move the saline 1712 from the saline bag 118.Thus, throughout this description, the direction of pump rotation willbe described for the return pump 212, the draw pump 208, and/or the ACpump 216, but those directions of rotations may be different if thepumps 208, 212, 216 are mounted or placed differently. Further, othertypes of pumps may be used, which would change how the pumps operate tomove the various liquids or air in the system 200. One skilled in theart would understand how to make these modifications to accomplishsimilar results as described in the following processes and steps.

Further, the volumes moved and the rates of movement in the apheresissystem 200 are mentioned or described in the Tables included herein.However, these volumes and rates depend on the size of the tubing, thesize of the bags used, the desired volume of the collected bloodcomponent (e.g., about 880 mL of plasma), and other considerations.State or country laws and other directives may govern the volumes andrates used in the apheresis system 200 or those volumes moved and therates of movement may be predetermined based on the direction of amedical professional or based on the characteristics of the donor 102.As such, the volumes moved and the rates of movement are only exemplary,but one skilled in the art would know which volumes moved and the ratesof movement to establish for the following steps and processes.

Thereinafter, the anticoagulant (AC) 1702 may be spiked, in step 1320.Spiking the anticoagulant 1702 may be a similar process to spiking thesaline 1712. For example, a tubing fitting 508 may be attached to the ACbag 114 by a user. The user may break a frangible, open a valve or otherdevice, or modify some structure that will allow AC 1702 to flow intothe anticoagulant tubing 110. In at least one example embodiment, aneedle may be inserted into the AC bag 114 by the user. At this point inthe process, the apheresis system 200 may appear as illustrated in FIG.17E. The cassette microcontroller 1004 may be signaled by the user,through a user interface or other user input device, that the AC bag 114has been connected or spiked. The status of the various components ofthe apheresis system 200, during this step, may be as shown below:

TABLE 4 Spike Anticoagulant Status Spike Anticoagulant Status Spin FlowRate Oc- Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Drawpump 208 0 No Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flowcontrol valve 286 Closed Saline flow control valve 288 Closed Firstfluid control valve 320A Open Second fluid control valve 320B Open Drawfluid control valve 320C Open Filler 460 0

In response to the signal from the user, the cassette microcontroller1004 may prime the AC 1702, in step 1324. To prime the AC 1702, thecassette microcontroller 1004 may direct the AC pump 216 to operate orrotate in the clockwise direction to pump anticoagulant 1702 from the ACbag 114 into the anticoagulant tubing 110, as illustrated in FIGS. 17Fand 17G. The donor feed tubing 104 may be blocked by a clamp, frangibledevice, or other structure. Thus, the AC 1702 does not flow from thedonor feed tubing 104 to the donor 102. Rather, the AC pump 216 may pushthe anticoagulant 1702 into the cassette inlet tubing 108A, into thesoft cassette 340, and partially into the loop inlet tubing 108B. In atleast one example embodiment, the AC 1702 flows through the first bypassbranch 358A, second bypass branch 358B, and/or the fluid sensor 316 butnot necessarily into the first tubing section 368A or second tubingsection 368B. Thus, the cassette microcontroller 1004 may close thefirst fluid control valve 320A to prevent the AC 1702 from flowing intothe first tubing section 368A, drip chamber 354, or second tubingsection 368B. Preplacing the AC 1702 into the first bypass branch 358A,second bypass branch 358B, and/or the fluid sensor 316 ensures properflow of whole blood during the first draw of whole blood from the donor102 and prevents a large volume of AC 1702 from being returned to thedonor 102 from the drip chamber 354 when red blood cells are returnedlater in the process.

To determine when to stop the AC pump 216, cassette microcontroller 1004may receive signals from the fluid sensor 316 and/or donor air detectionsensor 312 that indicate fluid is at or is passing the sensors 312, 316.Upon the fluid sensor 316 providing indication to the cassettemicrocontroller 1004 that the AC 1702 has reached the sensor 316, thecassette microcontroller 1004 may continue to direct the AC pump 216 fora predetermined period of time until a known volume of AC 1702 is pumpedthrough the second cassette port 360B and partially into the loop inlettubing 108B. Thus, the priming of the AC 1702 leaves the apheresissystem 200 in a state as illustrated in FIG. 17G. The status of thevarious components of the apheresis system 200, during this step, may beas shown below:

TABLE 5 Prime Anticoagulant Status Prime Anticoagulant Status Spin FlowRate Oc- Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Drawpump 208 0 No Return pump 212 0 Yes Anticoagulant pump 216 30 Plasmaflow control valve 286 Closed Saline flow control valve 288 Closed Firstfluid control valve 320A Closed Second fluid control valve 320B ClosedDraw fluid control valve 320C Open Filler 460 0

In at least one example embodiment, as illustrated in FIG. 17G, thedirection of the AC pump 216 may be reversed. At least a portion of theanticoagulant 1702 may be pumped back to the AC bag 114 and/or to aportion of the cassette inlet tubing 108A and/or anticoagulant tubing110. In at least one example embodiment, the cassette microcontroller1004 may direct the draw fluid control valve 320C to close to maintainthe AC in the first bypass branch 358A, second bypass branch 358B,and/or the fluid sensor 316. The donor air detection sensor 312 maydetermine when the AC 1702 stops passing the sensor 312 and send asignal to the cassette microcontroller 1004. Again, the cassettemicrocontroller 1004 may continue to direct the AC pump 216 for apredetermined period of time until a known volume of AC 1702 is pumpedback through the cassette inlet tubing 108A. Thus, the AC 1702 leavesthe apheresis system 200 in a state as illustrated in FIG. 17H. Theamount of anticoagulant left in the cassette inlet tubing 108A, thetubing connector 106, and/or the anticoagulant tubing 110 may bedetermined by the cassette microcontroller 1004 by an amount of timeafter the anticoagulant 1702 passes the donor air detection sensor 312.This process leaves some anticoagulant in cassette inlet tubing 108A butdecreases the amount of AC used to prevent issues with too much AC beingmixed with the incoming whole blood. The apheresis system 200 isprepared and ready to draw whole blood, in phase 1212 (FIG. 12 ). Thestatus of the various components of the apheresis system 200, duringthis step, may be as shown below:

TABLE 6 Prime AC Finish Status Prime AC Finish Status Spin Flow Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0No Return pump 212 0 No Anticoagulant pump 216 −30 Plasma flow controlvalve 286 Closed Saline flow control valve 288 Closed First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Closed Filler 460 0

FIG. 14 illustrates an example method 1400 representing the drawingplasma phase 1212, in accordance with embodiments of the presentdisclosure. The method 1400 may start with a start operation 1404 andend with operation 1440. The method 1400 may include more or fewer stepsor may arrange the order of the steps differently than those illustratedin FIG. 14 . The method 1400 may be, at least partially, executed as aset of computer-executable instructions executed by a computer system,processor, cassette microcontroller 1004, centrifuge microcontroller1104, and/or other devices and encoded or stored on a computer readablemedium. In at least one example embodiment, the method 1400 may beexecuted, at least partially, by a series of components, circuits,and/or gates created in a hardware device, such as a SOC, ASIC, and/or aFPGA. Hereinafter, the method 1400 shall be explained with reference tothe systems, devices, valves, pumps, sensors, components, circuits,modules, software, data structures, signaling processes, models,environments, apheresis systems, and/or methods, for example, asdescribed in conjunction with FIGS. 1-13 .

In step 1408, the donor 102 may be stuck with a needle. A phlebotomist,apheresis technician, or other medical professional may attach a needle,having a lumen, to the tubing fitting 504 and place the needle into ablood vessel (e.g., a vein) of the donor 102. Thus, the apheresis system200 may be fluidly connected to the donor 102 and be ready to draw wholeblood. Thus, the apheresis system 200 starts the draw plasma phase 1212in a state with the donor 102 ready to provide whole blood asillustrated in FIG. 17H. The status of the various components of theapheresis system 200, during this step, may be as shown below:

TABLE 7 Stick Donor Status Stick Donor Status Spin Flow Rate Oc- Open/Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0 YesReturn pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve286 Closed Saline flow control valve 288 Closed First fluid controlvalve 320A Closed Second fluid control valve 320B Closed Draw fluidcontrol valve 320C Closed Filler 460 0

The cassette microcontroller 1004 of the apheresis system 200 may beginto draw whole blood 1706, in step 1412. The cassette microcontroller1004 may direct the AC pump 216, the draw pump 208, and/or the returnpump 212 to operate by rotating in a clockwise rotation. The AC pump 216pushes anticoagulant 1702 towards the plasma collection bottle 122 sothat the AC 1702 mixes with the whole blood 1706 being drawn from thedonor 102 in the tubing connector 106 (and possibly in the donor feedtubing 104) and the other components distal to the tubing connector 106.The draw pump 208 and/or return pump 212 draws whole blood 1706 from thedonor 102 (and AC) into the soft cassette 340, flexible loop 524, and/orblood component separation bladder 536. During this process 1412, thecassette microcontroller 1004 and the centrifuge microcontroller 1008may communicate to inform the centrifuge microcontroller 1008 that thedraw has begun. In response to the indication of the draw beginning, thecentrifuge microcontroller 1008 may instruct the rotor and motorassembly 414 of the centrifuge assembly 400 to begin to rotate or spin.The initial rate of rotation may be slower to allow the blood componentseparation bladder 536 to become seated in the filler insert chamber 492and to draw the whole blood 1706 into the blood component separationbladder 536. The state of the apheresis system 200, during this step1412, may appear as in FIG. 17I. The status of the various components ofthe apheresis system 200, during this step, may be as shown below:

TABLE 8 Begin Draw Status Begin Draw Status Spin Flow Rate Oc- Open/Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 AF YesReturn pump 212 (AF + 50) Yes Anticoagulant pump 216 AF/15 Plasma flowcontrol valve 286 Open Saline flow control valve 288 Closed First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Closed Filler 460 800

In step 1416, the areas of the blood component separation bladder 536adjacent to the channel entrance 468, channel end 472, and/or channelpath jog 476 are primed with whole blood 1706. The cassettemicrocontroller 1004 stops operation of the return pump 212 butcontinues to operate the AC pump 216 and draw pump 208. Whole blood 1706is pushed through the first tubing section 368A, the drip chamber 354,and/or the second tubing section 368B. From the soft cassette 340, thewhole blood 1706 is pushed through the flexible loop 524 and into theblood component separation bladder 536 to the bladder free end 540B. Theanticoagulant pump 216 continues to operate to mix anticoagulant 1702from the anticoagulant bag 114 with the whole blood 1706 drawn from thedonor 102. The apheresis system 200 may appear as illustrated in FIG.17J during step 1416. The status of the various components of theapheresis system 200, during this step, may be as shown below:

TABLE 9 Prime Channel Status Prime Channel Status Spin Flow Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 AFYes Return pump 212 0 Yes Anticoagulant pump 216 AF/15 Plasma flowcontrol valve 286 Open Saline flow control valve 288 Closed First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Closed Filler 460 3200

Further communication occurs between the cassette microcontroller 1004and the centrifuge microcontroller 1008 to indicate the priming of thechannel. In response to these communications, the centrifugemicrocontroller 1008 directs the rotor and motor assembly 414 of thecentrifuge assembly 400 to begin to rotate or spin at higher revolutionsper minute (RPM).

Referring now to step 1420, the cassette microcontroller 1004 begins toexecute the first draw of plasma 1704 or other blood component from thewhole blood 1706. The cassette microcontroller 1004 continues to operatethe AC pump 216 to provide anticoagulant 1702 into the cassette inlettubing 108A to mix with the whole blood 1706 from the donor 102.Further, the cassette microcontroller 1004 continues to operate the drawpump 208 to move whole blood 1706 into the blood component separationbladder 536 to separate the plasma 1704 from the whole blood 1706. Togenerate the separation of the plasma 1704, the cassette microcontroller1004 informs the centrifuge microcontroller 1008 that the draw step hasbegun. In response to these communications, the centrifugemicrocontroller 1008 directs the rotor and motor assembly 414 of thecentrifuge assembly 400 to begin to rotate or spin at even higherrevolutions per minute (RPM), (e.g., substantially 5,000 RPM) to beginto separate the red blood cells 1708 from the plasma 1704, asillustrated in FIG. 17K. The draw pump 208 continues to push the plasma1704 through the flexible loop 524, the system static loop connector528, and into loop exit tubing 112. The draw process 1420 continuesuntil, at some point, as illustrated in FIG. 17L, the platelets 1710,separated from the whole blood 1706, reach line sensor 812, whichsignals the cassette microcontroller 1004 that the total amount ofplasma 1704 from the whole blood 1706 pushed into the blood componentseparation bladder 536 has been extracted and the cassettemicrocontroller 1004 moves to step 1424. The status of the variouscomponents of the apheresis system 200, during this step, may be asshown below:

TABLE 10 Draw Status Draw Status Spin Flow Rate Oc- Open/ Rate ComponentName (mL/min) clude? Closed? (RPM) Draw pump 208 AF Yes Return pump 2120 No Anticoagulant pump 216 AF/15 Plasma flow control valve 286 OpenSaline flow control valve 288 Closed First fluid control valve 320AClosed Second fluid control valve 320B Closed Draw fluid control valve320C Open Filler 460 5000

Additionally, or alternatively, a radial position of an interface 1709between the plasma 1704 and red blood cells (RBCs) 1708 and/or RBCinterface 1709, within the blood component separation bladder 536 may bedetermined as the RBC interface 1709 rises within the centrifugal fieldduring the separation of the plasma 1704. The radial position of theinterface 1709 may be determined by of the fluid to monitoring an inletpressure the centrifuge assembly 400. For example, sensor 808, disposedon or in the tubing 108B, may determine an inlet pressure to thecentrifuge assembly 400. Alternatively, another sensor disposed on or ina flow path into the centrifuge assembly 400 may determine an inletpressure. As the RBC interface 1709 rises within the blood componentseparation bladder 536, the plasma 1704 is displaced by red blood cells1708 in the RBC bed. For each incremental rise in the radial position(Dlta R) of the RBC interface 1709, the back pressure affecting theinlet pressure to the centrifuge assembly 400 (for example, the backpressure on the sensor 808 or another sensor) may increase by a multipleof Dlta R and an average value of the centrifugal field between theradial position of the channel entrance and the radial position of theRBC interface 1709 (G) and the RBC bed density less than the plasmadensity. More simply, the back pressure affecting the inlet pressure tothe centrifuge assembly may increase by: Dlta R×(RBC bed density—plasmadensity)×G. For example, in at least one example embodiment, the totalchange in back pressure from the initiation of RBC bed formation to theexit of RBCs at the center of rotation may be about 220 mmHg whenrotating the centrifuge at about 5000 RPM and initiating RBC bedformation at a radius of about 67 mm.

When platelets 1710, red blood cells, high hematocrit blood, and/orother blood component reach the line sensor 812, determined by thesensor 812 observing a change in color or other characteristic of thefluid, the cassette microcontroller 1004 determines whether the donationis complete, in step 1426. A complete donation means the entire amountof plasma 1704 required or desired has been drawn and put into theplasma collection bottle 122. In at least one example embodiment, thecassette microcontroller 1004 may determine, whether by weight orvolume, if a complete donation (e.g., about 880 mL) has been extracted.This situation may be as illustrated in FIG. 17L, where the plasma 1704has been extracted and is still present in loop exit tubing 112 andprovided to the plasma collection bottle 122 through plasma tubing 120.If it is an incomplete donation, meaning the plasma collection bottle122 has not reached its desired weight or volume limit, the process 1400may proceed NO to return step 1428. If it is a complete donation, themethod 1400 may proceed YES to the final return step 1432.

Alternatively, when the RBC interface 1709 is determined to be at theradially innermost position, the cassette microcontroller 1004determines whether the donation is complete, in step 1426. For example,the radially innermost position may be in a position adjacent the fillerloop connector 532. A complete donation means the entire amount ofplasma 1704 required or desired has been drawn and put into the plasmacollection bottle 122. In at least one example embodiment, the cassettemicrocontroller 1004 may determine, whether by weight or volume, if acomplete donation (e.g., about 880 mL) has been extracted. Thissituation may be as illustrated in FIG. 17L, where the plasma 1704 hasbeen extracted and is still present in loop exit tubing 112 and providedto the plasma collection bottle 122 through plasma tubing 120. If it isan incomplete donation, meaning the plasma collection bottle 122 has notreached its desired weight or volume limit, the process 1400 may proceedNO to return step 1428. If it is a complete donation, the method 1400may proceed YES to the final return step 1432.

By executing the return step 1428 when the RBC interface 1709 isdetermined to be at the radially innermost position instead of whenplatelets 1710, red blood cells, high hematocrit blood, and/or otherblood component reach the line sensor 812, the time to complete the drawprocess 1420 is reduced, reducing the overall time for method 1400 tocomplete.

In the return step 1428, as depicted in FIG. 17L, the cassettemicrocontroller 1004 instructs the draw pump 208 to stop and reversesthe direction of the return pump 212 to operate in a counterclockwisemotion to push the plasma 1704 from plasma collection bottle 122 throughthe plasma tubing 120, into the loop exit tubing 112, and toward thesoft cassette 340. The cassette microcontroller 1004 further directs thedraw fluid control valve 320C to close and to open both the first fluidcontrol valve 320A and the second fluid control valve 320B. Theseconfiguration changes cause the plasma 1704 to push the red blood cells1708 and the platelets 1710 out of the loop exit tubing 112, theflexible loop 524, the blood component separation bladder 536, throughthe drip chamber 354, and to the donor 102. Importantly, as can be seenin FIG. 17L, the filler 460 continues to rotate at the extraction speed(e.g. about 5,000 RPM) during this return step 1428. The system 200continues to push red blood cells 1708 back into the donor 102 until thecolor/pressure sensor 808 determines that plasma 1704 has passed throughsensor 808 and may have reached the drip chamber 354, as illustrated inFIG. 17M. At that point, valves 320B and 320A are closed again and thewhole blood 1706 may flow again through the first bypass branch 358A,the second bypass branch 358B, and/or the fluid sensor 316. The statusof the various components of the apheresis system 200, during this step1428, may be as shown below:

TABLE 11 Return Status Return Status Spin Flow Rate Oc- Open/ RateComponent Name (mL/min) clude? Closed? (RPM) Draw pump 208 0 No Returnpump 212 AF Yes Anticoagulant pump 216 0 Plasma flow control valve 286Open Saline flow control valve 288 Closed First fluid control valve 320AOpen Second fluid control valve 320B Open Draw fluid control valve 320CClosed Filler 460 5000

The return step 1428 moves to a second draw step 1420. The new drawproceeds in a similar fashion to step 1420 described above. However,there is a section of high hematocrit blood that remains in the dripchamber 354. By moving the new flow of whole blood 1706 through thefirst bypass branch 358A, second bypass branch 358B, and/or the fluidsensor 316, less high hematocrit blood is returned to blood componentseparation bladder 536, which red blood cells cannot have more plasma1704 extracted therefrom. Thus, the bypass provided by the soft cassette340 makes the removal of plasma 1704 from whole blood 1706 in the seconddraw step 1420 and subsequent draw steps more efficient.

The return step 1428 and the continued draw step 1420 will repeat forsome number of cycles. The final draw step 1420 may be as illustrated inFIG. 17N. The plasma 1704, within the plasma collection bottle 122, hasreached a desired and/or maximum amount, for example 880 mL, as isillustrated in FIG. 17N. When the plasma 1704 reaches a desired and/ormaximum amount in the plasma collection bottle 122, a final return isrequired in step 1432. The status of the various components of theapheresis system 200, during this return step, may be as shown below:

TABLE 12 Final Return Status Final Return Status Spin Flow Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0No Return pump 212 AF Yes Anticoagulant pump 216 0 Plasma flow controlvalve 286 Closed Saline flow control valve 288 Open First fluid controlvalve 320A Open Second fluid control valve 320B Open Draw fluid controlvalve 320C Closed Filler 460 5000

In step 1432, the total amount of plasma 1704 extracted from the donor102 is in the plasma collection bottle 122, and the apheresis system 200may push through remaining plasma 1704, red blood cells 1708, and anyother blood component into the donor 102. The cassette microcontroller1004 may instruct the plasma flow control valve 286 to close to maintainthe plasma donation in the plasma collection bottle 122. The return pump212 may continue to operate in the counterclockwise rotation to push thered blood cells 1708 and any plasma 1704 or other blood components backto the donor 102.

After or as part of the final return 1432, the saline 1712 may also bereturned to the donor 102, as illustrated in FIG. 17O, in step 1436. Inthis step 1436, the cassette microcontroller 1004 opens the saline flowcontrol valve 288 and leaves the first fluid control valve 320A and thesecond fluid control valve 320A open. The return pump 212 continues tooperate in the counterclockwise direction. The centrifugemicrocontroller 1008 stops the filler 460 from rotating. The saline 1712from the saline bag 118 is pushed through the blood component separationbladder 536, the drip chamber 354, and the various tubing back to thedonor 102. The various blood components left in the blood componentcollection set 500 are pushed back into the donor 102 along with someamount of saline 1712. The saline 1712 helps replenish fluids for thedonor 102 and is required in some jurisdictions. This saline 1712 returncontinues until a predetermined amount of saline 1712 is provided to theuser as determined by the weight or volume of saline 1712 that has leftthe saline bag 118. As illustrated in FIG. 17O, the plasma donation iscomplete. The status of the various components of the apheresis system200, during this step, may be as shown below:

TABLE 13 Saline Return Status Saline Return Status Spin Flow Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0No Return pump 212 AF (300) Yes Anticoagulant pump 216 0 Plasma flowcontrol valve 286 Closed Saline flow control valve 288 Open First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Open Filler 460 0

FIG. 15 illustrates an example method for unloading the plasma and bloodcomponent collection set 500 from the apheresis system 200, as describedin unloading phase 1216, in accordance with at least one exampleembodiment of the present disclosure. The method 1500 may starts with astart operation 1504 and ends with operation 1528. The method 1500 mayinclude more or fewer steps or may arrange the order of the stepsdifferently than those illustrated in FIG. 15 . The method 1500 may be,at least partially, executed as a set of computer-executableinstructions executed by a computer system, processor, cassettemicrocontroller 1004, centrifuge microcontroller 1104, and/or otherdevices and encoded or stored on a computer readable medium. In at leastone example embodiment, the method 1500 may be executed, at leastpartially, by a series of components, circuits, and/or gates created ina hardware device, such as a SOC, ASIC, and/or a FPGA. Hereinafter, themethod 1500 shall be explained with reference to the systems, devices,valves, pumps, sensors, components, circuits, modules, software, datastructures, signaling processes, models, environments, apheresissystems, and/or methods, for example, as described in conjunction withFIGS. 1-14 .

The channels are evacuated, in step 1508. In at least one exampleembodiment, the cassette microcontroller 1004 operates the draw pump 208in a counterclockwise direction to continue to drive saline 1712substantially completely out of the blood component separation bladder536 and the rest of the blood component collection set 500, asillustrated in FIG. 17P. At some point, substantially the total amountof blood components and/or saline 1712 gets pushed back into the donor102, in which case all pumps 216, 208, and 212 cease operation. Thefluid control valve 320A, first fluid control valve 320A, saline flowcontrol valve 288, and any other valve may be shut by the cassettemicrocontroller 1004. Once the various valves are shut, only a minuteamount of saline 1712 or no saline at all should remain within the bloodcomponent collection set 500. The state of the apheresis system 200 maybe as illustrated in FIG. 17Q. The status of the various components ofthe apheresis system 200, during this step, may be as shown below:

TABLE 14 Channel Evacuation Status Channel Evacuation Status Spin FlowRate Oc- Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Drawpump 208 −AF Yes Return pump 212 0 Yes Anticoagulant pump 216 0 Plasmaflow control valve 286 Closed Saline flow control valve 288 Closed Firstfluid control valve 320A Open Second fluid control valve 320B Open Drawfluid control valve 320C Open Filler 460 0

The blood component collection set 500 may be sealed, in step 1512, asillustrated in FIG. 17R. The sealing of blood component collection set500 may include clamping the donor feed tubing 104 that leads to thedonor 102 and fusion sealing the tubing at various places. The sealingmay be a fusion of the tubes, as the tubes may be thermoplastic, asillustrated in FIG. 17R. For example, the anticoagulant tubing 110, thesaline tubing 116, the plasma tubing 120 (above the plasma flow controlvalve 286), and the donor feed tubing 104 are all heat fused to separatethe AC bag 114, the plasma collection bottle 122, the saline bag 118,and the donor 102 from the rest of the blood component collection set500. The status of the various components of the apheresis system 200,during this step, may be as shown below:

TABLE 15 Seal Kit Status Seal Kit Status Spin Flow Rate Oc- Open/ RateComponent Name (mL/min) clude? Closed? (RPM) Draw pump 208 0 Yes Returnpump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve 286Closed Saline flow control valve 288 Closed First fluid control valve320A Closed Second fluid control valve 320B Closed Draw fluid controlvalve 320C Closed Filler 460 0

In step 1516, the needle may be taken out of the donor 102, as shown in17R. The status of the various components of the apheresis system 200,during this step, may be as shown below:

TABLE 16 Unstick Donor Status Unstick Donor Status Spin Flow Rate Oc-Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Draw pump 208 0Yes Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow controlvalve 286 Closed Saline flow control valve 288 Closed First fluidcontrol valve 320A Closed Second fluid control valve 320B Closed Drawfluid control valve 320C Closed Filler 460 0

The blood component collection set 500 may be unloaded from theapheresis system 200, in step 1520, which entails reversing at leastsome of the procedures described in conjunction with FIGS. 13 and 16 .The status of the various components of the apheresis system 200, duringthis step, may be as shown below:

TABLE 17 Unload Status Unload Status Spin Flow Rate Oc- Open/ RateComponent Name (mL/min) clude? Closed? (RPM) Draw pump 208 0 No Returnpump 212 0 No Anticoagulant pump 216 0 Plasma flow control valve 286Open Saline flow control valve 288 Open First fluid control valve 320AOpen Second fluid control valve 320B Open Draw fluid control valve 320COpen Filler 460 0

Once unloaded, the used blood component collection set 500 may bedisposed of as medical waste. The plasma collection bottle 122 may besealed on plasma tubing 120, as shown in FIG. 17S. The sealed areas mayprevent any liquid from seeping from the plasma collection bottle 122,the saline bag 118, or the anticoagulant bag 114. Once sealed, theplasma collection bottle 122 may be removed and used in whateverprocedure the plasma is required. The rest of the items may be discardedas medical waste and the procedure is completed, in step 1524, as shownin FIG. 17T. The status of the various components of the apheresissystem 200, at the end of the procedure, may be as shown below:

TABLE 18 Complete Procedure Status Complete Procedure Status Spin FlowRate Oc- Open/ Rate Component Name (mL/min) clude? Closed? (RPM) Drawpump 208 0 No Return pump 212 0 No Anticoagulant pump 216 0 Plasma flowcontrol valve 286 Open Saline flow control valve 288 Open First fluidcontrol valve 320A Open Second fluid control valve 320B Open Draw fluidcontrol valve 320C Open Filler 460 0

FIG. 16 illustrates an example method 1600 for inserting a disposableinto the filler of the apheresis system 200 in accordance with at leastone example embodiment of the present disclosure. The method 1600 maystart with a start operation 1604 and end with operation 1632. Themethod 1600 may include more or fewer steps or may arrange the order ofthe steps differently than those shown in FIG. 16 . The method 1600 maybe, at least partially, executed as a set of computer-executableinstructions executed by a computer system, processor, cassettemicrocontroller 1004, centrifuge microcontroller 1104, and/or otherdevices and encoded or stored on a computer readable medium. In at leastone example embodiment, the method 1600 may be executed, at leastpartially, by a series of components, circuits, and/or gates created ina hardware device, such as a SOC, ASIC, and/or a FPGA. Hereinafter, themethod 1600 shall be explained with reference to the systems, devices,valves, pumps, sensors, components, circuits, modules, software, datastructures, signaling processes, models, environments, apheresissystems, and/or methods, for example, as described in conjunction withFIGS. 1-15 .

A filler 460 of an apheresis system 200 may be provided, in step 1608.The filler 460 may be a component of the apheresis system 200 andconfigured to receive at least a portion of the blood componentcollection set 500. In at least one example embodiment, the filler 460is mounted on a split-housing pivot axis 406 that pivots to expose aninternal portion of the upper housing 404B, including the filler 460. Auser may pivot the upper housing 404B to expose the separation insertchannel 466 or, in at least one example embodiment, the filler 460 maybe automatically pivoted by a motor or other mechanical device. Thispivoting and/or loading may be as described in conjunction with FIGS.4D-4F and/or FIGS. 6A-6C above.

A blood component collection set 500, including a blood componentseparation bladder 536, may be provided, in step 1612. The bloodcomponent collection set 500 may be prepackaged and extracted from thepackaging. A user may expose the blood component separation bladder 536for insertion into the separation insert channel 466, including ensuringthat the bladder free end 540B is positioned at the channel path jog 476of the separation insert channel 466 and the filler loop connector 532is positioned at the loop connection area 454. With the blood componentseparation bladder 536 positioned properly, the user may form the bloodcomponent separation bladder 536 substantially into the shape ofseparation insert channel 466 and the channel path jog 476, in step1616, as shown in FIGS. 5F-5H. Thus, the user may form the bloodcomponent separation bladder 536 generally into a circular shape or anyother shape the generally matches the shape of the separation insertchannel 466.

The user may insert the formed blood component separation bladder 536into the separation insert channel 466 of the filler 460, as shown inFIGS. 5G and 5H, with the bladder free end 540B of the blood componentseparation bladder 536 inset into the channel path jog 476 of theseparation insert channel 466, in step 1620. The user may insert theblood component separation bladder 536 into the separation insertchannel 466 generally at a central position within filler insert chamber492. Centrifugal forces will generally align the blood componentseparation bladder 536 automatically into the correct position withinthe filler insert chamber 492. However, if not positioned wherecentrifugal forces may act on the blood component separation bladder536, the blood component separation bladder 536 may be ejected from theseparation insert channel 466. Once positioned, the blood componentseparation bladder 536 may be fixed in place.

In step 1624, the user connects the filler loop connector 532 of theblood component separation bladder 536 to the loop connection area 454of the separation insert channel 466. A mechanical connection may bemade by the user snapping the filler loop connector 532 into the loopconnection area 454. The dimensions and physical features of the fillerinsert chamber 492 holds the blood component separation bladder 536,with the filler loop connector 532 stable in the loop connection area454, in a stable position allowing the blood component separationbladder 536 to migrate into the center of the filler insert chamber 492during operation of the centrifuge 400. The portion of the flexible loop524, remaining outside or outboard of the filler 460 may be mounted tothe loop capture arm 416. This mounting of the flexible loop 524 allowsfor the 1ω/2ω action of the centrifuge 400.

After the flexible loop 524 is mounted, the upper housing 404B isflipped into position, in step 1628. Thus, the filler 460 may be pivotedby the hinge axis 406 (e.g., hinge) into the interior of the systemhousing 204. The centrifuge housing 404 is rotated with blood componentcollection loop 520 passing through a loop access clearance 436 in thecentrifuge split-housing 404. When the blood component collection loop520 is loaded in the loop loading position 520A, a portion of the bloodcomponent collection loop 520 may be partially contained, held, and/orsupported by a loop containment bracket 426, as described in conjunctionwith FIGS. 4A-4C. The access panel 224 may be pivoted into the closedposition allowing for the operation of the system 200.

The exemplary systems and methods of this disclosure have been describedin relation to apheresis methods and systems. However, to avoidunnecessarily obscuring the present disclosure, the precedingdescription omits a number of known structures and devices. Thisomission is not to be construed as a limitation of the scope of theclaimed disclosure. Specific details are set forth to provide anunderstanding of the present disclosure. It should, however, beappreciated that the present disclosure may be practiced in a variety ofways beyond the specific detail set forth herein.

Furthermore, while the exemplary aspects, embodiments, and/orconfigurations illustrated herein show the various components of thesystem collocated, certain components of the system may be locatedremotely, at distant portions of a distributed network, such as a LANand/or the Internet, or within a dedicated system. Thus, it should beappreciated, that the components of the system may be combined into oneor more devices, such as the cassette node 904 and the centrifuge node908, or collocated on a particular node of a distributed network, suchas an analog and/or digital telecommunications network, a packet-switchnetwork, or a circuit-switched network. It will be appreciated from thepreceding description, and for reasons of computational efficiency, thatthe components of the system may be arranged at any location within adistributed network of components without affecting the operation of thesystem. For example, the various components may be located in a switchsuch as a PBX and media server, gateway, in one or more communicationsdevices, at one or more users' premises, or some combination thereof.Similarly, one or more functional portions of the system could bedistributed between a telecommunications device(s) and an associatedcomputing device.

Furthermore, it should be appreciated that the various links connectingthe elements may be wired or wireless links, or any combination thereof,or any other known or later developed element(s) that is capable ofsupplying and/or communicating data to and from the connected elements.These wired or wireless links may also be secure links and may becapable of communicating encrypted information. Transmission media usedas links, for example, may be any suitable carrier for electricalsignals, including coaxial cables, copper wire and fiber optics, and maytake the form of acoustic or light waves, such as those generated duringradio-wave and infra-red data communications.

Also, while the flowcharts have been discussed and illustrated inrelation to a particular sequence of events, it should be appreciatedthat changes, additions, and omissions to this sequence may occurwithout materially affecting the operation of the disclosed embodiments,configuration, and aspects.

A number of variations and modifications of the disclosure can be used.It would be possible to provide for some features of the disclosurewithout providing others.

In yet another embodiment, the systems and methods of this disclosurecan be implemented in conjunction with a special purpose computer, aprogrammed microprocessor or microcontroller and peripheral integratedcircuit element(s), an ASIC or other integrated circuit, a digitalsignal processor, a hard-wired electronic or logic circuit such asdiscrete element circuit, a programmable logic device or gate array suchas PLD, PLA, FPGA, PAL, special purpose computer, any comparable means,or the like. In general, any device(s) or means capable of implementingthe methodology illustrated herein can be used to implement the variousaspects of this disclosure. Exemplary hardware that can be used for thedisclosed embodiments, configurations and aspects includes computers,handheld devices, telephones (e.g., cellular, Internet enabled, digital,analog, hybrids, and others), and other hardware known in the art. Someof these devices include processors (e.g., a single or multiplemicroprocessors), memory, nonvolatile storage, input devices, and outputdevices. Furthermore, alternative software implementations including,but not limited to, distributed processing or component/objectdistributed processing, parallel processing, or virtual machineprocessing can also be constructed to implement the methods describedherein.

In yet another embodiment, the disclosed methods may be readilyimplemented in conjunction with software using object or object-orientedsoftware development environments that provide portable source code thatcan be used on a variety of computer or workstation platforms.Alternatively, the disclosed system may be implemented partially orfully in hardware using standard logic circuits or VLSI design. Whethersoftware or hardware is used to implement the systems in accordance withthis disclosure is dependent on the speed and/or efficiency requirementsof the system, the particular function, and the particular software orhardware systems or microprocessor or microcomputer systems beingutilized.

In yet another embodiment, the disclosed methods may be partiallyimplemented in software that can be stored on a storage medium, executedon programmed general-purpose computer with the cooperation of acontroller and memory, a special purpose computer, a microprocessor, orthe like. In these instances, the systems and methods of this disclosurecan be implemented as program embedded on personal computer such as anapplet, JAVA® or CGI script, as a resource residing on a server orcomputer workstation, as a routine embedded in a dedicated measurementsystem, system component, or the like. The system can also beimplemented by physically incorporating the system and/or method into asoftware and/or hardware system.

Although the present disclosure describes components and functionsimplemented in the aspects, embodiments, and/or configurations withreference to particular standards and protocols, the aspects,embodiments, and/or configurations are not limited to such standards andprotocols. Other similar standards and protocols not mentioned hereinare in existence and are considered to be included in the presentdisclosure. Moreover, the standards and protocols mentioned herein andother similar standards and protocols not mentioned herein areperiodically superseded by faster or more effective equivalents havingessentially the same functions. Such replacement standards and protocolshaving the same functions are considered equivalents included in thepresent disclosure.

The present disclosure, in various aspects, embodiments, and/orconfigurations, includes components, methods, processes, systems and/orapparatus substantially as depicted and described herein, includingvarious aspects, embodiments, configurations embodiments,subcombinations, and/or subsets thereof. Those of skill in the art willunderstand how to make and use the disclosed aspects, embodiments,and/or configurations after understanding the present disclosure. Thepresent disclosure, in various aspects, embodiments, and/orconfigurations, includes providing devices and processes in the absenceof items not depicted and/or described herein or in various aspects,embodiments, and/or configurations hereof, including in the absence ofsuch items as may have been used in previous devices or processes (e.g.,for improving performance, achieving ease, and\or reducing cost ofimplementation).

The foregoing discussion has been presented for purposes of illustrationand description. The foregoing is not intended to limit the disclosureto the form or forms disclosed herein. In the foregoing DetailedDescription for example, various features of the disclosure are groupedtogether in one or more aspects, embodiments, and/or configurations forthe purpose of streamlining the disclosure. The features of the aspects,embodiments, and/or configurations of the disclosure may be combined inalternate aspects, embodiments, and/or configurations other than thosediscussed above. This method of disclosure is not to be interpreted asreflecting an intention that the claims require more features than areexpressly recited in each claim. Rather, as the following claimsreflect, inventive aspects lie in less than all features of a singleforegoing disclosed aspect, embodiment, and/or configuration. Thus, thefollowing claims are hereby incorporated into this Detailed Description,with each claim standing on its own as a separate preferred embodimentof the disclosure.

Moreover, though the description has included description of one or moreaspects, embodiments, and/or configurations and certain variations andmodifications, other variations, combinations, and modifications arewithin the scope of the disclosure (e.g., as may be within the skill andknowledge of those in the art, after understanding the presentdisclosure). It is intended to obtain rights which include alternativeaspects, embodiments, and/or configurations to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges, or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges, or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

1. A method for collecting a blood component, the method comprising:drawing whole blood into a centrifuge; spinning the centrifuge to causecentrifugal force to act on the whole blood to separate the whole bloodinto a least a first blood component and a second blood component thatis different from the first blood component; extracting the first bloodcomponent from the centrifuge; detecting when the second blood componentis about to be extracted from the centrifuge; and after the second bloodcomponent is detected and while the centrifuge continues to spin,flowing the separated first blood component back towards the centrifugeto move at least the second blood component from the centrifuge.
 2. Themethod of claim 1, wherein the first blood component includes plasma,platelets, red blood cells, high hematocrit blood, or a combinationthereof.
 3. The method of claim 2, wherein the second blood componentincludes plasma, platelets, red blood cells, high hematocrit blood, or acombination thereof.
 4. The method of claim 2, wherein the second bloodcomponent includes red blood cells.
 5. The method of claim 1, whereinthe centrifuge spins at a first speed when separating the first bloodcomponent from the whole blood.
 6. The method of claim 5, wherein thecentrifuge continues to spin at the first speed when flowing theseparated first blood component back towards the centrifuge.
 7. Themethod of claim 6, wherein the centrifuge spins at a second speed whendrawing the whole blood into the centrifuge.
 8. The method of claim 7,wherein the second speed is slower than the first speed.
 9. The methodof claim 1, wherein the centrifuge is configured to receive a bloodcomponent collection set and the blood component collection set isconfigured to receive the first blood component.
 10. The method of claim9, wherein the method further includes inserting the blood componentcollection set into the centrifuge.
 11. The method of claim 9, whereinthe blood component collection set includes a blood component separationbladder that separates the first blood component.
 12. The method ofclaim 11, wherein the centrifuge includes a filler, and the filler isconfigured to spin the blood component separation bladder.
 13. Themethod of claim 12, wherein the filler includes a separation insertchannel that is configured to receive the blood component separationbladder.
 14. The method of claim 13, the method further includesinserting the blood component separation bladder into the separationinsert channel of the filler.
 15. The method of claim 1, whereindetecting when the second blood component is about to be extracted fromthe centrifuge includes detecting an interface between the first bloodcomponent and the second blood component.
 16. The method of claim 15,wherein the method further includes detecting a radial position of theinterface between the first blood component and the second bloodcomponent in the centrifuge.
 17. The method of claim 1, wherein themethod further includes monitoring an inlet pressure of the whole bloodentering the centrifuge.
 18. The method of claim 17, wherein themonitoring of the inlet pressure includes receiving an output signalfrom a sensor disposed at an inlet of the centrifuge.
 19. The method ofclaim 18, wherein the method further includes determining a backpressure at the inlet of the centrifuge.
 20. The method of claim 19,wherein the method further includes equating a change in back pressurewith a radial position of the interface between the first bloodcomponent and the second blood component in the centrifuge.